FDAnews Device Daily Bulletin

BAXTER HEALTHCARE SIGNS CONSENT DECREE FOR CGMP VIOLATIONS IN MAKING INFUSION PUMPS

July 5, 2006
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Baxter Healthcare has signed a consent decree with the FDA related to violations of current good manufacturing practices (cGMPs) in making two brands of infusion pumps, the agency said June 29.

Under the agreement approved by the U.S. District Court for the Northern District of Illinois, Baxter will stop manufacturing and distributing all models of its Colleague volumetric infusion pump and Syndeo patient controlled analgesic syringe pump in the U.S. until:It corrects manufacturing deficiencies; andThe devices are made in compliance with the FDA's cGMP requirements and quality systems regulation (QSR).

Infusion pumps are electronic devices used for intravenous and other forms of drug delivery. They provide medication in a continuous or intermittent manner for a prolonged period of time, the FDA said. "If they don't work properly, patients are put at risk," said Daniel Schultz, director of the FDA's Center for Devices and Radiological Health.

The FDA April 28 issued recommendations for healthcare providers and biomedical engineers to take additional safety steps beyond those issued by the manufacturer when using Baxter's Colleague pump.

The device "has exhibited a variety of problems, including under-infusion, battery failures, false alarms and failure to alarm," the agency said. ()a href="http://www.fdanews.com/ddl/33_27/" target=_blank>