FDAnews Device Daily Bulletin


May 4, 2006

The FDA has issued recommendations for health care providers and biomedical engineers to take additional safety steps beyond those issued by the manufacturer when using the COLLEAGUE Volumetric Infusion Pump manufactured by Baxter Healthcare Corporation.

The device "has exhibited a variety of problems, including under-infusion, battery failures, false alarms and failure to alarm," the agency said.

Baxter has issued four urgent safety notices and recalls for the devices over the past year, the agency noted. Instructions included in these notices are: avoid using the pumps in situations where delaying or interrupting therapy in order to reprogram or replace a malfunctioning pump may be life threatening; have a backup pump available to mitigate any disruption of infusion therapy; monitor patients and check the pumps frequently; report any problems as soon as possible to Baxter and the FDA; and if your facility relies primarily or entirely on the devices, consider evaluating other options for infusion therapy.

A complete list of legally marketed infusion pump devices is available on the FDA web site at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm) by using "FRN" in the "Product Code" field, the agency says.

The FDA notice on Baxter's COLLEAGUE infusion pumps can be viewed at http://www.fda.gov/cdrh/safety/042806-baxter.html (http://www.fda.gov/cdrh/safety/042806-baxter.html).