On July 13, 2010, the U.S. Food and Drug Administration required Baxter Healthcare Corp. to take specific steps to carry out the April 2010 recall of all Colleague Volumetric Infusion Pumps (CVIP) and to provide customers with a refund, a replacement pump, or lease termination.
According to the FDA, it is requiring Baxter to provide replacements or refunds for these recalled devices. This action reflects the agency’s commitment to protect patients by removing unsafe infusion pumps and to promote public health through assuring the availability of safe and effective alternatives. The FDA has been working with Baxter since 1999 to correct numerous flaws in the CVIP, that have been the subject of several Class I recalls for battery failures, inadvertent powering off, service data errors, and other issues. In June 2006, the FDA obtained a consent decree of permanent injunction in which Baxter agreed to stop manufacturing and distributing all models of the CVIP until the company corrected manufacturing deficiencies and brought the pumps into compliance with the law. On April 8, 2010, Baxter submitted a proposed correction schedule for the CVIP that the FDA found unacceptable. The FDA ordered the recall and replace or refund action pursuant to the authority granted to the agency by the 2006 consent decree.
Clinicians and home-care users may continue to use Colleague pumps during the transition period, but the FDA recommends replacement of Colleague infusion pumps as soon as practicable. Baxter will provide a Transition Guide no later than September 11, 2010 to help customers through the transition and installation of a new infusion pump system.
The Transition Guide will include the following information:
- Detailed information on the refund and replacement programs.
- Instructions on how to complete the Certificate of Medical Necessity, which must be returned promptly in order to continue receiving support and be eligible for the replacement/refund.
- An accurate and complete list of the currently known risks associated with the continued use of the Colleague infusion pumps, including all open recalls and deficiencies known to Baxter at the time the Transition Guide is distributed.
- Suitable FDA approved or cleared alternatives to the Colleague infusion pumps, and their respective manufacturers.
- Ways to minimize disruption and reduce risk to patients during the transition period.
- The need to have appropriate training for staff prior to using alternative infusion pumps.
- The need to verify and validate the alternative pumps prior to use within the healthcare facility.
- A list of consultants who can assist facilities with the verification and validation of the alternative infusion pumps prior to use.
For more information on the FDA Recall, Refund or Replace order, click here.
For Q & A about the Baxter Colleague Recall, Refund or Replace order, click here.
Colleague Infusion Pump Photo from Baxter Healthcare US Website