Adding an additional agent from a different drug class is the general management approach recommended by NCCN as well as adjusting either the intensity or frequency of dosing. Dopamine antagonists, metoclopramide, thiethylperazine, butyrophenones e. Routine around-the-clock administration should be considered, rather than as needed. Also, while not likely to be effective, anecdotal evidence suggests that switching to a different 5-HT3 may be efficacious NCCN.
Studies have demonstrated that all of the 5-HT3 antagonists are effective and have mild, infrequent side effects, although optimal antiemetic therapy requires concomitant dexamethasone or methylprednisolone, unless the patient can not tolerate corticosteroids NCCN.
According to the NCCN guidelines, dolasetron mesylate, granisetron, and ondansetron are effective in preventing acute emesis but are less effective for delayed emesis compared with palonosetron. Palonosetron is effective for preventing both delayed and acute emesis and is the preferred medication for patients undergoing moderate emetic risk chemotherapy NCCN.
In the trial data submitted to the Food and Drug Adminsitration FDA for licensure, palonosetron achieved equivalent or superior results compared to the control arms ondansetron and dolasetron , especially with regard to delayed nausea. The side effect and safety profile of palonosetron has been demonstrated to be the same as dolasetron mesylate and ondansetron but it has a slightly higher tissue binding affinity for the 5-HT3 receptor and a significantly longer serum half-life than other 5-HT3 antagonists.
Palonosetron is administered intravenously and is approved by the FDA as a single dose of 0. Repeat dosing of palonosetron in the days following chemotherapy e. NCCN antiemesis guidelines for the use of antiemetics in radiotherapy are based on the site of radiation and whether radiotherapy is combined with chemotherapy; when radiotherapy is combined with chemotherapy, prophylaxis is dictated by the emetogenic potential of the chemotherapy regimen. For upper abdomen radiation, NCCN guidelines recommend pretreatment for each day of radiation treatment with either oral ondansetron or oral granisetron.
NCCN guidelines do not recommend primary treatment for patients receiving radiation to other sites. Nausea and vomiting are common in pregnancy. Hyperemesis gravidarum, a severe and intractable form of nausea and vomiting during pregnancy, may result in weight loss, nutritional deficiencies, and dehydration. The peak incidence occurs at 8 to 12 weeks of pregnancy, and symptoms usually resolve by week The American College of Obstetrics and Gynecology ACOG recommend a step-wise approach to alleviating nausea and vomiting in pregnancy, beginning with prevention at the time of conception.
Two studies found that women who take a multi-vitamin at the time of conception were less likely to need medical attention for vomiting. While there is little published evidence regarding the efficacy of dietary changes for prevention or treatment of nausea and vomiting of pregnancy, a small study showed that protein meals were more likely to relieve nausea and vomiting of pregnancy than carbohydrate and fatty meals.
Other conservative treatments recommended by ACOG included ginger capsules and electrical stimulation or acupressure at the P6 or Neguian point on the inside of the wrist.
Women with more complicated nausea and vomiting of pregnancy may need pharmacologic therapy. While many conventional antiemetics have been used for nausea and vomiting of pregnancy, it is important to note that no drug has been approved by the FDA for the treatment of nausea and vomiting in pregnancy since Benedictine an antiemetic no longer available in the U. According to ACOG guidelines, pharmacologic treatment of nausea and vomiting of pregnancy should begin with pyridoxine vitamin B6.
If there is no improvement, doxylamine Unisom should be added with the pyridoxine. Doxylamine and pyridoxine are currently available separately without a prescription in the U. Several studies involving more than , exposures have found this combination to be safe with regard to fetal exposure.
Please let us know if this helps. Always on the go For a long time I kept my dosage under the required daily maximum. Every once in a while I would take mgs and it helped with no apparent side effects. Over the last few months I have noticed that I am consistently taking higher dosages than recommended mg daily. I first started taking this medication for lower back and hip pain. I have Adult ADHD but have never taken medication for it tramadol seems to have a positive affect on this however.
Every few months I slowly reduce my dosage in order to make sure I have the capability of weaning myself off. I drink a ton of caffeine! Coke, Coffee, 5 hour energy, etc..
Here is the issue…I am always on the go, so reducing the dosage is hard because it lowers my energy and mood so taking it helps me manage activities. I am an executive and massively involved in activities. I think that while I started to take it for the pain relief, I now take it for the energy and difficulty of reducing dosage. Any recommendations on decreasing dosage, managing this or alternative recommendations?
Thanks for the help. Also, I take the mg time release capsules available in Mexico. It does seem like you have developed quite a tolerance to tramadol. Tramadol might just not be working for you and is actually in a totally distinct class of opioids in and of itself. And I would certainly suggest that you consult your prescribing doctor with full disclosure to seek a professional opinion. I think that you need to consult a pharmacist. It may help to also seek out a prescription for a strong opioid like hydrocodone or oxycodone during the days before treatment.
He is a recovering addict. He just filled his prescrition and ten days later his bottle is almost empty. He said he was doubling the dosage. The directions were to take two pills every six hours. He has also gone through a bottle of Xanax within nine days. Last time he ran out of Tramadol he started to have seizure symtoms but more thrashing like.
I believe his body is going through withdrawl at this point. Is he taking lethal doses?? The dosage and use sounds like drug abuse. Is it safe to have a couple glasses of wine? I know that I am de Addiction Blog 8: Check with your doctor first.
Perhaps there is another opioid medication which you might need to consider, as it seems that your tolerance to tramadol has increased. Alternative options for pain relief include hydrocodone and oxycodone, although these are more addictive and powerful painkillers. It is fustating and sickening to think that doctors will not tell the patient of what could happen-ie,. If I wee told the facts and the possible consequence,I would have un out of that offece not waked….
I took two Tamadol and 4 tamadol at 50mg. I still feel the pain in my foot and intermittant stabinh pain-thank God is is rare. I do not know what to do, I am deapeate. I do not take any during the day so the max per day and at one time is mg. I have been slightly increasing a quarter of the round pill at a time and refuse to go about mg. After reading several stories and researching, I just want to be sure that this amount is safe.
Thank you for your time and knowledge. I also take antihistamen and a few paracetamol during day up to 6 paracetamol over counter strength. Should I be concerned? Have you thought about seeing a psychologist to learn new ways of coping or to talk about drug use in general? She has been an alcohol abuser for over 40 years. Moderate The anticholinergic effects of sedating H1-blockers may be enhanced when combined with other antimuscarinics. Clinicians should note that anticholinergic effects might be seen not only on GI smooth muscle, but also on bladder function, the eye, and temperature regulation.
Additive drowsiness may also occur when antimuscarinics are combined with sedating antihistamines. Minor No specific drug interactions were identified with systemic agents and apraclonidine during clinical trials. Theoretically, apraclonidine might potentiate the effects of CNS depressant drugs such as the anxiolytics, sedatives, and hypnotics, including barbiturates or benzodiazepines. This risk may be more clinically significant with long-acting beta-agonists i.
Moderate Due to the primary CNS effects of aripiprazole, caution should be used when aripiprazole is given in combination with other centrally-acting medications including benzodiazepines and other anxiolytics, sedatives, and hypnotics. Drugs with a possible risk for QT prolongation and TdP that should be used cautiously and with close monitoring with hydroxyzine include arsenic trioxide. Drugs with a possible risk for QT prolongation and TdP that should be used cautiously and with close monitoring with hydroxyzine include artemether; lumefantrine.
Major Asenapine should be avoided with hydroxyzine. Asenapine has been associated with QT prolongation. According to the manufacturer of asenapine, the drug should be avoided in combination with other agents also known to have this effect.
In addition, using drugs that can cause CNS depression, such as sedating H1-blockers, concomitantly with asenapine may increase both the frequency and the intensity of adverse effects such as drowsiness, sedation, and dizziness. Moderate Carisoprodol is metabolized to meprobamate, a significant CNS depressant. Additive effects of sedation and dizziness, which can impair the ability to undertake tasks requiring mental alertness, may occur if carisoprodol is taken with sedating H1-blockers.
Utilize appropriate caution if carisoprodol is coadministered with another CNS depressant. Drugs with a possible risk for QT prolongation and TdP that should be used cautiously and with close monitoring with hydroxyzine include atomoxetine. Moderate An enhanced CNS depressant effect may occur when sedating H1-blockers are combined with other CNS depressants including neuromuscular blockers. Atropine; Hyoscyamine; Phenobarbital; Scopolamine: Major An enhanced CNS depressant effect may occur when azelastine is combined with other CNS depressants including sedating H1-blockers; avoid concurrent use.
Drugs with a possible risk for QT prolongation and TdP that should be used cautiously and with close monitoring with hydroxyzine include azithromycin.
Moderate An enhanced CNS depressant effect may occur when sedating H1-blockers are combined with other CNS depressants including skeletal muscle relaxants, such as baclofen.
Drugs with a possible risk for QT prolongation and TdP that should be used cautiously and with close monitoring with hydroxyzine include bedaquiline. Belladonna Alkaloids; Ergotamine; Phenobarbital: Moderate Coadministration can potentiate the CNS effects e. Moderate Amphetamines may pharmacodynamically counteract the sedative properties of some antihistamines, such as the sedating H1-blockers.
Bismuth Subcitrate Potassium; Metronidazole; Tetracycline: Drugs with a possible risk for QT prolongation and TdP that should be used cautiously and with close monitoring with hydroxyzine include metronidazole. Bismuth Subsalicylate; Metronidazole; Tetracycline: Moderate Drowsiness has been reported during administration of carbetapentane. An enhanced CNS depressant effect may occur when carbetapentane is combined with other CNS depressants including sedating h1-blockers.
Major Buprenorphine has been associated with QT prolongation and has a possible risk of torsade de pointes TdP. Hydroxyzine has a possible risk for QT prolongation and TdP and should be used cautiously and with close monitoring with buprenorphine. FDA-approved labeling for some buprenorphine products recommend avoiding use with Class 1A and Class III antiarrhythmic medications while other labels recommend avoiding use with any drug that has the potential to prolong the QT interval.
In addition, if concurrent use of sedating H1-blockers and buprenorphine is necessary, consider a dose reduction of one or both drugs because of the potential for additive pharmacological effects.
Hypotension, profound sedation, coma, respiratory depression, or death may occur during co-administration of buprenorphine and other CNS depressants.
Prior to concurrent use of buprenorphine in patients taking a CNS depressant, assess the level of tolerance to CNS depression that has developed, the duration of use, and the patient's overall response to treatment. Evaluate the patient's use of alcohol or illicit drugs.
Monitor patients for sedation or respiratory depression. Moderate The combination of buspirone and other CNS depressants, such as sedating h1-blockers, can increase the risk for sedation. Use together with caution. If a CNS depressant needs to be used with butorphanol, use the smallest effective dose and the longest dosing frequency of butorphanol.
Moderate Concomitant administration of metaxalone with other CNS depressants can potentiate the sedative effects of either agent. Moderate COMT inhibitors, such as entacapone or tolcapone, should be given cautiously with other agents that cause CNS depression, including sedating H1-blockers, due to the possibility of additive sedation.
Moderate Due to the CNS effects of cariprazine, caution should be used when cariprazine is given in combination with other centrally-acting medications including benzodiazepines and other anxiolytics, sedatives, and hypnotics like hydroxyzine. Major Periodically monitor electrolytes and ECGs in patients receiving concomitant treatment with ceritinib and hydroxyzine; an interruption of ceritinib therapy, dose reduction, or discontinuation of therapy may be necessary if QT prolongation occurs.
Ceritinib causes concentration-dependent prolongation of the QT interval. Postmarketing data indicate that hydroxyzine also causes QT prolongation and torsade de pointes TdP. Major Dry mouth, drowsiness and other antihistamine-related side effects may occur in patients receiving cetirizine. Due to the duplicative and additive nature of the pharmacology of cetirizine, concurrent use of sedating antihistamines H1-blockers is not recommended.
Moderate Drugs that can cause CNS depression, if used concomitantly with iloperidone, may increase both the frequency and the intensity of adverse effects such as drowsiness, sedation, and dizziness.
Caution should be used when iloperidone is given in combination with other centrally-acting medications, such as sedating H1-blockers. Drugs with a possible risk for QT prolongation and TdP that should be used cautiously and with close monitoring with hydroxyzine include chloroquine. Chlorpheniramine; Guaifenesin; Hydrocodone; Pseudoephedrine: Major Chlorpromazine should be used cautiously and with close monitoring with hydroxyzine.
Chlorpromazine, a phenothiazine, is associated with an established risk of QT prolongation and torsade de pointes TdP. Drugs with a possible risk for QT prolongation and TdP that should be used cautiously and with close monitoring with hydroxyzine include ciprofloxacin.
QT prolongation and ventricular arrhythmias, including torsade de pointes TdP and death, have been reported with cisapride. Because of the potential for TdP, use of hydroxyzine with cisapride is contraindicated. Drugs with a possible risk for QT prolongation and TdP that should be used cautiously and with close monitoring with hydroxyzine include citalopram.
Moderate Clobazam, a benzodiazepine, may cause drowsiness or other CNS effects. Additive drowsiness may occur when clobazam is combined with CNS depressants such as sedating H1-blockers.
In addition, caution is recommended when administering clobazam with medications extensively metabolized by CYP2D6 such as diphenhydramine because clobazam has been shown to inhibit CYP2D6 in vivo and may increase concentrations of drugs metabolized by this enzyme. Major Clozapine should be used cautiously and with close monitoring with hydroxyzine.
Treatment with clozapine has been associated with QT prolongation, torsade de pointes TdP , cardiac arrest, and sudden death. The manufacturer of clozapine recommends caution during concurrent use with medications known to cause QT prolongation. Major Promethazine should be used cautiously and with close monitoring with hydroxyzine. Promethazine, a phenothiazine, is associated with a possible risk for QT prolongation.
In addition, additive anticholinergic effects may be seen when promethazine is used concomitantly with other drugs with antimuscarinic activity like sedating H1-blockers. Clinicians should note that antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function, the eye, and temperature regulation.
Because promethazine causes pronounced sedation, an enhanced CNS depressant effect or additive drowsiness may occur when it is combined with other CNS depressants including sedating H1-blockers. Major Monitor ECGs for QT prolongation and monitor electrolytes in patients receiving crizotinib concomitantly with hydroxyzine. An interruption of therapy, dose reduction, or discontinuation of therapy may be necessary for crizotinib patients if QT prolongation occurs.
Crizotinib has been associated with concentration-dependent QT prolongation. Postmarketing data indicate that hydroxyzine also causes QT prolongation as well as torsade de pointes TdP.
Major Cyclobenzaprine should be used cautiously and with close monitoring with hydroxyzine. Cyclobenzaprine is structurally similar to tricyclic antidepressants. Tricyclic antidepressants have been reported to prolong the QT interval, especially when given in excessive doses or in overdosage settings. Cyclobenzaprine is associated with a possible risk of QT prolongation and torsades de pointes TdP , particularly in the event of acute overdose In addition, the anticholinergic effects of hydroxyzine are moderate and may be enhanced when combined with other medications with anticholinergic effects, such as cyclobenzaprine.
Clinicians should note that antimuscarinic effects might be seen not only on GI smooth muscle, but also on bladder function, the eye, and temperature regulation. Dasabuvir; Ombitasvir; Paritaprevir; Ritonavir: Drugs with a possible risk for QT prolongation and TdP that should be used cautiously and with close monitoring with hydroxyzine include ritonavir. Drugs with a possible risk for QT prolongation and TdP that should be used cautiously and with close monitoring with hydroxyzine include dasatinib.
Drugs with a possible risk for QT prolongation and TdP that should be used cautiously and with close monitoring with hydroxyzine include certain anthracyclines. Acute cardiotoxicity can occur during administration of daunorubicin, doxorubicin, epirubicin, or idarubicin; cumulative, dose-dependent cardiomyopathy may also occur.
Sinus tachycardia is the most common arrhythmia, but other arrhythmias such as supraventricular tachycardia SVT , ventricular tachycardia, heart block, and premature ventricular contractions PVCs have been reported.
Drugs with a possible risk for QT prolongation and TdP that should be used cautiously and with close monitoring with hydroxyzine include degarelix. Minor Although desloratadine is considered a 'non-sedating' antihistamine, dose-related sedation has been noted. For this reason, it would be prudent to monitor for drowsiness during concurrent use of desloratadine with CNS depressants such as other H1-blockers. Clinically relevant QTc prolongation may occur with deutetrabenazine.
Postmarketing data indicate that hydroxyzine causes QT prolongation and torsade de pointes TdP. Additionally, concurrent use of deutetrabenazine and drugs that can cause CNS depression, such as hydroxyzine, may have additive effects and worsen drowsiness or sedation.
Advise patients about worsened somnolence and not to drive or perform other tasks requiring mental alertness until they know how deutetrabenazine affects them. Moderate Co-administration of dexmedetomidine with sedating antihistamines is likely to lead to an enhancement of CNS depression.
Drugs with a possible risk for QT prolongation and TdP that should be used cautiously and with close monitoring with hydroxyzine include quinidine.
The implanted infusion system components consist of a Medtronic SynchroMed implantable drug infusion pump and an Intrathecal Catheter. These notifications provide clinicians with information to help identify and manage issues that impact the safe and reliable delivery of therapy using the SynchroMed Implantable Infusion System. Patients and caregivers should be aware of the signs and symptoms associated with intrathecal drug therapy complications and contact their physicians immediately if they hear a device alarm or experience symptoms of a drug overdose or underdose.
Patients are encouraged to maintain regular follow-up appointments with their physicians; however, if they experience a change or return of symptoms or hear a device alarm, they should contact their physician immediately. The affected products may have excessively high flow rates. As a result, medications could be delivered too quickly from the balloon to the surgical site and cause patient toxicity due to the rapid influx of medication.
This can lead to serious illness, including seizure, abnormal heart rhythms and death. Elderly patients and patients with low body mass are at high risk of these complications. The Symbios GOPump Rapid Recovery System is a disposable local pain management system that consists of a small balloon that is inflated with a local anesthetic medication.
The medication is delivered slowly through tubes from the balloon to the surgical site. Please see the Recall Notice with listing of all the lot numbers affected. Customers who have purchased the affected devices were notified by letter dated May 10, about the problem and follow-up letters were sent on May 14, and May 30, notifying customers of additional recalled lots.
Symbios is working to secure all affected product and have it returned. The FreeStyle InsuLinx Blood Glucose Meter measures sugar glucose in blood drawn from the fingertips of people with diabetes to monitor blood sugar levels. Consumers who are using the FreeStyle InsuLinx Meter should immediately take one of the following actions to address this issue with your meter: Access a software update to install on your meter to resolve the issue at: The software update will allow you to maintain settings and historical data on your meter.
Replacements are available, and Abbott will send a meter to you immediately upon request. Healthcare professionals who have FreeStyle InsuLinx Blood Glucose Monitoring Kits are advised to immediately discontinue dispensing them to your patients, and to arrange for product return and replacement, call Abbott Diabetes Care customer service at When the GemStar Lithium battery voltage level drops below 2. Additionally, infusion settings and event history logs will be erased as a result of this device malfunction.
The affected units were manufactured and distributed between February and April The customer notification letter stated that lithium batteries that are older than three 3 years should be replaced. Facilities that periodically retrieve the history logs from their GemStar Infusion System should consider retrieving them more often to reduce the amount of history log information that would be lost should this failure occur.
The OneTouch Verio IQ Blood Glucose Meter is an over-the counter single-use device intended to be used by a patient outside of a health care facility as an aid to monitor the effectiveness of diabetes control measures sugar glucose in blood drawn from the fingertips. If the OneTouch Verio IQ Meter unexpectedly turns off and enters set-up mode after turning it back on, blood glucose may be extremely high, and you should call your health care professional.
Call LifeScan Customer Service at for support. The firm issued a recall notification letter informing affected customers. The Alaris PC unit will produce an audible alarm and the attached modules will display a Communications Error message with a flashing red light. Refer to the Recall Notice for additional details.
When the Alaris PC unit experiences a communication error, the programmed infusion s will continue as programmed. However, no further key presses on the Alaris PC unit have an effect on the system except for the System On key which allows the user to power down the device. Powering down of the device results in termination of all infusions. If you experience a communication error on the Alaris PC unit, contact CareFusion Customer Advocacy at , 24 hours a day, 7 days a week or by email at customerfeedback carefusion.
Animas Corporation Insulin Infusion Pump: The component issue may trigger the pumps to sound a false alarm or warning related to one of the following: The Animas Insulin Pump also has a software limitation that will impact the ability of the pump to function past December 31, EST to schedule shipment of your free replacement pump.
Customers with technical questions or who want to report a concern should contact Customer Technical Support Center at The reason for the recall is that the flow restrictor bead may become displaced from its fitting which may permit solutions to flow at a higher rate than intended.
This product may cause serious adverse health consequences, including death. These kits were distributed between Sept. Refer to the Recall Notice for a list of kit part numbers. The Symbios Disposable Infusion Pump Kit is a disposable, self-contained infusion system using an inflatable elastomeric reservoir to mechanically provide percutaneous infusion of prescribed solutions at a pre-set rate for post-operative pain management.
Customers are asked to: Refer to the Recall Notice for details. Medtronic Drug Infusion Pumps: The use of unapproved drugs can lead to intermittent or permanent pump motor stall and cessation of drug infusion. A cessation of drug infusion may cause serious adverse health consequences, including death.
These infusion pumps were manufactured from May through November and distributed from April through November Model numbers can be found in the recall notice. To minimize the potential for motor stall, the firm recommended that healthcare professionals only use the approved drugs that are identified in the SynchroMed Infusion Pump labeling or drugs approved by FDA that are labeled for use with the SynchroMed II pump.
Do not use compounded drugs, unapproved concentrations, or unapproved formulations with the SynchroMed Infusion Pump Refer to the Medtronic Medical Device Safety Notification, sent November 9, to healthcare professionals which includes detailed information about this issue. In addition to the Healthcare Professional Letter, the safety notification provided a white paper documenting the Increased Risk of Motor Stall and Loss of or Change in Therapy when Unapproved Drug Formulations are used with the SynchroMed Pump and a summary of the drugs that are approved to be used with the SynchroMed.
Baxter has initiated a voluntary recall of its Buretrol Solution Sets because the ball-valve feature may not function as expected. Baxter has determined that the ball-valve component is allowing air to flow past the valve and enter the tubing once the pre-measured amount of fluids is completely administered to the patient.
Products were manufactured from April 30, through July 26, and were distributed from May 1, through August 16, For products affected see Recall Notice. On September 7, , Baxter Healthcare sent an Urgent Product Recall letter to affected customers informing them of the problem with the ball-valve feature.
Customers were asked to do the following: Contact Baxter for instructions on how to return the affected product. Hospira Symbiq Infusion System Touchscreen: These devices may not respond to user selection, may experience a delayed response or may register a different value from the value selected by the user. Failure of the touchscreen to respond to user input could result in a delay or interruption in therapy or over delivery or under delivery of medication if the user does not confirm the programmed values on the pump''s confirmation screen before starting the infusion.
All serial numbers for these models are affected by this recall. The Symbiq infusion pump is a prescription device used to deliver controlled amounts of medications or other fluids to patients through intravenous, intra-arterial, epidural, and other acceptable routes of administration.
The touchscreen is used to control infusion pump settings for patient therapy. Customers were instructed not to return affected Symbiq infusion pumps. The letter lists steps that users may take to confirm that infusion settings are correctly entered as well instructions for how to stop an infusion. Health care providers experiencing the described issue should remove the impacted device from use and contact their institution''s biomedical or clinical engineering department to perform the touchscreen test described in the Symbiq technical service manual.
If the biomedical or clinical engineering department identifies that the device is not working properly, contact Hospira. When this occurs, the patient may receive continuous infusion at a rate greater than expected.
As a result, this product may cause serious adverse health consequences, including death. See the Recall Notice for a listing of affected product numbers. Customers should identify all affected products within your inventory and Quarantine the affected products. Fluids, such as water, cleaning solutions, and nutrition source solutions, may enter into the keypad of the Automix control module and may cause the Automix to generate an incorrect device response to an Automix operator's key press.
The intermittent electrical failures may cause the motors on the Automix to pump nutrition solution when not programmed to do so, or may cause the Automix to stop compounding before it has finished appropriately mixing the Total Parenteral Nutrition TPN Solution. Causes for the intermittent electrical failures have not been determined. The incorrect key response failure and the intermittent electrical failures may lead to improperly mixed TPN solutions e.
Automix Compounder Systems are automated nutrition compounders that use weight-based gravimetric measuring, often controlled by software, to provide compounding of total parenteral nutrition TPN solutions to a patient.
Customers should discontinue using the Automix compounder and transition to an alternative option as soon as possible. This could cause a potential for fluid ingress which could lead to a keypad malfunction, causing the infusion to stop with alarm. When infusion stops, serious injury or death may result. The pump module is intended for healthcare facilities that use infusion for the delivery of fluids, drugs, blood, and blood products using continuous or intermittent delivery through intravenous, intra-arterial, subcutaneous, epidural, enteral, or irrigation of fluid spaces routes of administration.
The pump module is used for adults, children, and newborns. Customers were asked to visually examine the pump module keypad overlay for obvious signs of overlay separation.
Medical Device Recall Notification letter. The problem may look different on different pump modules. Carefusion informed customers that they will contact their facility by phone within 60 days of receiving the letter to schedule a visit to replace the door assembly on their affected pump module. Braun Infusomat Space Infusion System: Braun Infusomat Space Infusion System, due to the potential for breakage of the anti free flow clip catch located inside the infusion pump door.
Breakage may occur when the IV set anti free flow clip catch is inserted improperly into the pump and the pump door is forced closed. Misloading of the anti free flow clip catch may create the potential for free flow of medication. Free flow, especially of narrow therapeutic range drugs, can cause life-threatening effects and injuries. Affected pumps were distributed from November 6, , to December 29, See the Recall Notice for a list of affected model numbers.
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