Carefusion Infusion Pump Recall Issued Due to Software Problem
About 17,000 CareFusion Alaris PC electronic drug infusion pumps have been recalled due to a software problem that may cause the devices to freeze if they lose their wireless internet connection, potentially causing serious injury and death.
The FDA issued a notification of the Alaris recall on October 15, categorizing it as a Class I medical device recall; meaning that the agency believes the malfunction is likely to cause serious injury or death in patients. Neither the FDA nor Carefusion Corporation, the manufacturer, indicate that there have been any injuries related to the electronic infusion pump recall.
Electronic infusion pumps inject programmed amounts of drugs and other substances into patients bodies through intravenous, intra-arterial and epidural injections.
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The Alaris PC Unit’s screen could freeze if it suffers a communication error through its wireless network connection. This can delay therapy and prevent program changes to current infusions. It also means that infusions continue unchanged and cannot be modified. Attempting to stop the pump from delivering drugs to the patient can cause the Alaris to shut down, delaying or interrupting therapy and potentially causing serious injury and/or death.
The infusion pump recall affects about 17,000 Alaris PC Units model 8015 that contain logic boars P.N TC10005522 or TC10005572. A link to the serial numbers of affected units is available here (pdf). The recalled pumps were manufactured or serviced between December 2008 and September 2009.
The company has notified all registered owners and issued a tip sheet on using the units until they can receive a hardware update that will fix the problem. The FDA recommends that any institution or user who experiences the problem should remove the device from service and contact the CareFusion Recall Center immediately at SupportCenter@carefusion.com.
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