Not your best Colleague
WASHINGTON
- MedWatch, the Safety Information and Adverse Event Reporting Program of the U.S. Food and Drug Administration (FDA), recommended all health-care providers take safety steps when using the Colleague Volumetric Infusion Pump made by Baxter Healthcare Corp. The pump has exhibited problems, including under-infusion, battery failures, false alarms, and failure to alarm. Over the past year, Baxter has issued four urgent safety notices and recalls for Colleague infusion pumps. In addition to recommendations made by Baxter when using the Colleague, FDA strongly recommended: if possible, don’t use Colleague where delaying or interrupting therapy in order to reprogram or replace a malfunctioning pump may be life-threatening; have a contingency plan to mitigate any disruption of infusion therapy (e.g., have a back-up pump available); monitor patients and check the pumps frequently; report any problems ASAP to Baxter and FDA, and consider evaluating other options for infusion therapy if your facility relies primarily or entirely on Colleague pumps. Other short-term options that may be appropriate for certain IV therapies include gravity drip and flow control devices (e.g., buretrol, volutrol, micro tubing, and flow control tubing devices). FDA is mindful of concerns about the availability of replacement units and is working with Baxter to resolve problems with the Colleague pump as quickly as possible. Read the complete MedWatch summary at www.fda.gov/medwatch/safety/2006/safety06.htm#colleague2.
