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Baxter Signs Consent Decree for Infusion Pumps

Baxter Healthcare Corp. has signed a consent decree with FDA to stop making and distributing two brands of infusion pumps until manufacturing deficiencies are corrected. The models are the Colleague Volumetric Infusion Pump and the Syndeo Patient Controlled Analgesic Syringe Pump. The action stems from a June 2005 inspection that found inadequate management controls over quality system operations and CAPA procedures, as well as design defects.

June 30, 2006

1 Min Read
Baxter Signs Consent Decree for Infusion Pumps

The management-controls issues had also been raised during inspections conducted in 2000 and 2002. During the 2005 inspection, Baxter placed a worldwide hold on both products after the design defects were discovered. CDRH has always been suspicious about the reliability of infusion pumps, and this incident will reinforce that.

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