The U.S. Food and Drug Administration (FDA) has cleared for marketing a modified Colleague Volumetric Infusion Pump which addresses many of the problems that prompted a series of Class I recalls and a product seizure in 2005.
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 product seizure.
“The clearance of the Colleague pump is an example of FDA’s efforts to protect the public throughout a product’s life cycle,” said Daniel Schultz, M.D., director, FDA’s Center for Devices and Radiological Health. “FDA works with companies to ensure products are safe and effective at every step of the process whether it be pre-market development, product evaluation or after the device is actually on the market.”
The 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.