Baxter Recalls Infusion Pumps over System Error

Baxter International's Baxter Healthcare Corp. is recalling some of its infusion pumps over a serious system error, according to the FDA.The FDA on Thursday designated the recall as Class I.Regulators believe the infusion pumps--used to deliver medicines, blood, blood products, and other intravenous fluids--could cause serious injury or death because the system error could potentially cause an interruption or delay in therapy, according to the FDA.Baxter has already received more than 3500 reports of malfunctioning due to "System Error 322" incidents, also called "link switch error (low)" occurrences. Nine resulted in nine severe adverse events, though there have been no deaths reported.

The recall involves Sigma Spectrum Infusion Pumps with Master Drug Library, model No. 35700BAX and 35700ABB, made from July 1, 2005 through January 15, 2014, and distributed from February 20, 2013 through January 15, 2014. A System Error 322 takes place when the pump improperly detects that the door is open when it is physically closed, causing it to halt infusion, sound an alarm, and flash a warning light.

Chris Newmarker is senior editor of MPMN and Qmed. Follow him on Twitter at @newmarker.