FDA Requirements for Colleague Infusion Pump Recall (Sept. 2010)

Here is information on the steps Baxter Healthcare has to take in order to carry out the recall of its Colleague volumetric infusion pumps. The recall was ordered by FDA earlier this year because of Baxter's long-term failure to correct serious problems with Colleague pumps.

Baxter is required to give Colleague pump owners a cash refund or a replacement pump at no charge. Also, facilities that lease Colleague pumps may terminate the lease without penalty. The company must also give a full refund for unused Colleague pump spare parts, batteries, and consumables.

The company's Transition Guide will give details on the refund or replacement program, provide a list of alternative pumps, and offer suggestions to help minimize disruption and patient risks during the transition period. The Guide will be issued no later than September 11, 2010.

Baxter's guide will also describe how to fill out a Certificate of Medical Necessity. It is important to submit this certificate by November 14, 2010 in order to receive a replacement or refund, and so that Baxter can continue to provide service and maintenance for existing units.

Baxter is required to complete the transition by July 14, 2012. After that, they must stop all service and support for Colleague products. Until then, clinicians and home-care users can continue to use their Colleague pumps, and Baxter will continue to provide service and maintenance. But FDA recommends replacing the pumps as soon as it is safely possible.

For people who continue to use Colleague pumps during the transition period, FDA recommends having a backup plan in case a pump fails. The plan should include how to get another pump and tubing quickly when caring for high-acuity patients, and how to handle high-risk infusions or infusions in vulnerable patient populations.

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Science & Technology

Tags:

• Baxter
• Colleague Infusion Pump
• FDA
• Recall
• Refund
• Patient Safety