The FDA has cleared for marketing Baxter's Colleague infusion pump that was the subject of recalls and product seizures in 2005. From the FDA press release:
Confusing display screens, software defects, swollen batteries and other defects
could have resulted in the pumps either shutting down or under- or over-delivering
critical medication and fluids to patients and were associated with serious
injuries and deaths.
In June 2006, the manufacturer, Baxter Healthcare Corporation signed a consent
decree with FDA detailing the steps that must be taken before the Colleague
pump would meet appropriate regulatory requirements and could be sold again.
The agreement resolved a court action by FDA that began with the October 2005
Colleague device was one of the most commonly used volumetric pumps in the
U.S. when FDA asked U.S. marshals to seize all pumps stored in Baxter Healthcare's
northern Illinois warehouses in October 2005. However, hospitals and clinics
were allowed to continue to use pumps already in their possession, guided
by instructions provided by Baxter Healthcare.
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.
FDA will continue working with Baxter Healthcare to ensure that infusion
pumps are safe and effective for their intended use. FDA is committed to
assuring that the company fully addresses the issues identified in the consent
decree. Pumps seized by the government are not in distribution at this time.
Baxter Healthcare is located in Deerfield, Ill.
I'd hate to guess what Baxter's market share is at the present time. Nor would I care to contemplate the what this little detour did to their product roadmap and future product introductions. Welcome back Colleague.