FDA Issues Requirements for Baxter Healthcare Infusion Pump Recall

Company must provide transition guide for facilities using Colleague infusion pumps

SILVER SPRING, Md., July 13 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today 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.

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Baxter is responsible for recalling as many as 200,000 CVIP currently in use in the United States.  Under the FDA's requirements, Baxter will also provide a transition guide to assist customers affected by the recall. The guide will include a list of FDA-cleared or approved pump alternatives, suggestions to help minimize disruption and patient risk during the transition period, and detailed information on the refund, replacement, and lease termination programs.

"FDA is requiring Baxter to provide replacements or refunds for these recalled devices," said Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health. "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."

Baxter will continue to provide batteries, spare parts, and service for the affected pumps during the transition period for customers who submit a Certificate of Medical Necessity to Baxter. The certificate, provided by Baxter, asks for information such as the number of CVIP currently in use, serial numbers, and the anticipated date that the CVIP will be removed from use. After receiving the completed certificate, Baxter will continue service for 24 months after today's date, or until the customer has transitioned to another pump.

Baxter will complete the recall and the replace or refund programs by July 14, 2012.

"Baxter's Colleague infusion pumps are commonly found in many hospitals and facilities," said Dr. Shuren. "Considering the size of the recall the FDA reached out directly to the hospital community in order to determine what would best fit their needs in a transition plan."

Infusion pumps are devices that deliver fluids, including nutrients and medications, into a patient's body in a controlled manner. They are widely used in hospitals, other clinical settings and, increasingly, in the home, because they allow a greater level of accuracy in fluid delivery.

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.

For more information:

FDA's Final Order to Baxter to recall and refund or replace Colleague Volumetric Infusion Pumps

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm218753.htm

Questions and Answers about the Baxter Recall, Refund, and Replacement Action

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm210768.htm

FDA Statement on Baxter Recall, May 3, 2010

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm210664.htm

FDA's Infusion Pump Web Page

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/GeneralHospitalDevicesandSupplies/InfusionPumps/default.htm

SOURCE U.S. Food and Drug Administration