Baxter’s Modified Colleague Pump Gets FDA Clearance
The FDA has cleared Baxter Healthcare Corporation’s modified Colleague volumetric infusion pump. The Colleague was one of the most commonly used volumetric pumps when it was seized by the FDA and withdrawn from the market after a series of recalls in October 2005. The Colleague pump was withdrawn because of serious injuries and deaths that may have been related to confusing display screens, software defects, swollen batteries and other defects that could have resulted in the pumps either shutting down or under- or over-delivering critical medication and fluids to patients.
Baxter signed a consent decree with the FDA in June 2006 detailing the steps that had to be taken before the Colleague pump would meet appropriate regulatory requirements and could be sold again. This agreement resolved a court action by the FDA that began with the October 2005 product seizure.
Baxter Healthcare’s pre-market submission for the modified pump included:
- “Detailed testing to demonstrate that the pump meets the latest electromagnetic testing compatibility standard;
- Complete redesign of the battery protection circuit;
- Improved interface to warn user of battery depletion problems;
- Complete documentation to support unit and system-level software verification and validation of the final finished device to alleviate software problems that could lead to over and under infusion;
- A human factors evaluation to alleviate concerns about silent failures and unclear operating instructions;
- Information to support hardware redesigns; and a rewritten user manual.”
February 28, 2007 Related topics: Product Approval & Certification, Quality, Safety, Errors, Pharmaceuticals