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FDA orders recall of Baxter’s Colleague Volumetric Infusion Pumps

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The FDA has notified health care professionals and consumers of a letter sent to Baxter on April 30 ordering the company to recall and destroy all Colleague Volumetric Infusion Pumps currently used in the United States — there may be as many as 200,000 pumps currently in use.

This action is based on a longstanding failure to correct many serious problems with the pumps. Beginning in 1999, the pumps have been the subject of several class I recalls for battery swelling, inadvertent power off, and service data errors.

In June 2006, Baxter agreed to stop manufacturing and distributing all models of the pump until the company corrected manufacturing deficiencies and until devices in use were brought into compliance. Although Baxter has made numerous changes to the Colleague Volumetric Infusion pumps, the changes have not corrected the product defect leading to the permanent injunction, according to the agency.

On April 8, 2010, Baxter submitted a proposed correction schedule to the FDA stating that the company did not plan to begin the latest round of corrections pumps until May 2012. The proposal also stated that Baxter does not anticipate completion of the proposed corrections until 2013.

On this schedule, a device with known safety concerns would remain in use by patients requiring specialized care until 2013, which the FDA found to be unacceptable and is now ordering Baxter to:

• Recall and destroy all Colleague Volumetric Infusion Pumps.
• Reimburse customers for the value of the recalled device.
• Assist in finding a replacement for customers.

Last month, the FDA announced a new initiative to address safety problems associated with infusion pumps. As part of its initiative, the FDA is moving to establish additional premarket requirements manufacturers will be expected to meet, in part through static testing in FDA’s facilities before device submissions. The FDA will also hold a public workshop on infusion pump design in May, and the agency is raising public awareness of the issue among health care workers and patients.

Hospitals and other users of Baxter’s Colleague Volumetric Infusion pumps will receive further instruction and information from Baxter and the FDA regarding their transition.

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