Consumer Alert: FDA Orders Class 1 Recall of Baxter International's Colleague Volumetric Infusion Pumps

August 10, 2005

Many patients require accurate dosing of multiple prescriptive medications and several medical device manufacturers have designed and marketed devices for the automated delivery of prescriptive medications.  Computerized devices such as this are often used in the treatment of critically ill patients.  On July 21, 2005 the U.S. Food and Drug Administration took the unusual step of ordering a Class 1 Recall of Baxter International's Colleague Volumetric Infusion Pumps after receiving “hundreds of complaints” from various hospitals and patients.  A Class 1 Recall is the FDA's most serious Recall classification and is based upon the Agency's conclusion that there is “a reasonable probability that using the affected product will cause serious injury or death."

The FDA's Recall decision was prompted by reports of the deaths of three patients and the serious illnesses and injuries suffered by six other patients as a result of the unexpected shut down of their Baxter Colleague pumps.  

For example, one of the common problems with these pumps that was cited by the FDA was the location of the “On/Off” button.  The pump design placed the “On/Off” button right next to the “Start” button.  This switch placement has led to the inadvertent shut down of these machines by nurses and other health care professionals who had actually intended that the pumps either begin or continue drug therapy.  This switch placement design defect is potentially fatal for a very simple reason - -  the location and placement of the switches causes people to turn the pumps “Off” when they actually intend to turn them “On.”

Because some hospitals depend entirely on Baxter pumps the FDA is not ordering that they all be taken out of service.  Instead, the FDA is advising hospitals to attempt to use other manufacturer's pumps in critical care cases if at all possible.  If a Baxter pump still in hospital use malfunctions and shuts down then the FDA has ordered that the particular malfunctioning pumps be removed from service.  Unfortunately, for some patients that action may come too late to prevent serious injury or death. 

If you or someone you know is using a Baxter Colleague pump you should discuss these product defect problems with the treating health care provider. If you or someone you know would like further information concerning a malfunctioning Baxter International Colleague Volumetric Infusion Pump, and you wish to consult with us, please call Gary Wilson at 612-349-8413.   You can also send him an e-mail by clicking on this link: contact us.

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