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Carefusion Recalls Faulty Alaris Pump Modules

En Español

Author: Lauren Cohrs
Posted on May 17, 2013 in bad-drug-blog

On June 29, 2012, Carefusion issued a voluntary Class 1 recall of certain Alaris Pump Modules in response to concerns regarding hazardous product flaws. Alaris Pump Modules aid in infusion processes by controlling the flow of medications and prescribed fluids into the patients body during intravenous (IV) and intra-arterial (IA) injections, as well as other medical procedures. Unfortunately, model 8100 of the Alaris Pump Module has been reported to have a mechanical error which causes the machine to stall, specifically during high infusion rates of above 900ml/hr.

Carefusion Healthcare believes that this malfunction could be dangerous for patients receiving infusions with the product. Ceasing flow of the medicine suddenly at high infusion rates may cause devastating side effects and may even lead to fatalities.

Recalled Alaris Pump Modules were manufactured between the dates of August 1, 2010 and July 31, 2011. A complete list of affected product serial numbers can be found here.

What to Do with Recalled Products

Both the U.S. Food and Drug Administration and Carefusion have deemed this product unsafe and unreliable. Therefore, anyone who possesses a model 8100 Alaris Pump Module should only continue use of the module if they feel that the benefits are greater than the risks of utilizing the malfunctioning product.

Carefusion has sent a Medical Device Recall Notification to all consumers who had previously purchased the recalled Alaris Pump Module. This statement, released on July 20, 2012, advises owners of the module to consider implementing an alternative product to avoid any risks. The company also recommends purchasing a backup product to ensure safety in the event of the module stalling.

Patients should understand that this Class 1 recall signifies a high potential for danger and even death while using a dysfunctional recalled product.

What to Do with Malfunctioning Recalled Products

Anyone who has a recalled Alaris Pump Module model 8100 that has stalled should end use of the product immediately and contact CareFusion Support Center by calling 1-888-812-3229. If you or a loved one has suffered from an adverse reaction related to the recall, contact the FDA MedWatch Adverse Event Reporting Program.

Keep up with the latest medical information at bad-drug.net.

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