DEERFIELD, Ill.—As part of a recall agreement, Baxter International will offer replacement infusion pumps or refunds to owners of Colleague pumps and will execute the recall over the next two years to minimize disruption to patient care, the company said in a July 13 news release.
Baxter announced on May 3 that it would recall Colleague infusion pumps from the U.S. market pursuant to an order under its existing June 2006 consent decree with the U.S. Food and Drug Administration (FDA).
The FDA alleged that the Colleague pump had a design flaw that could result in it shutting down during therapy, which could result in serious injury or death.
Infusion pumps are electronic devices intended to control delivery of solutions and medications to patients. They are used in situations where medication must be administered intravenously or through other routes, in a continuous or intermittent manner, for a prolonged period of time.
The replacement option permits customers to exchange Colleague infusion pumps for Sigma Spectrum next-generation smart pumps. Alternatively, Colleague pump owners may receive the lesser of the pump's depreciated value, which will be no less than $1,500 per single-channel pump and $3,000 per triple-channel pump, or the purchase price.
Customers who did not purchase their pumps directly from Baxter must provide proof of purchase to verify the purchase price in order to qualify for a refund, according to the company.
Baxter said it will also permit U.S. pump lessees to terminate their leases without penalty upon the return of the devices.
"Baxter's goal is to support a seamless transition by providing choices that best address the needs of our hospital customers and minimize disruption to the delivery of patient care," said Peter J. Arduini, president of Baxter's Medication Delivery business. "We are continuing to work with Sigma to increase production capacity of the SPECTRUM pump in order to meet the anticipated demand for this device."
During the 24-month transition period, customers may continue to use Colleague infusion pumps and receive service and support provided that a certificate of medical necessity form has been completed.
Baxter said it will be providing a transition guide to help customers in replacing Colleague infusion pumps.
"Our actions in the U.S. as well as our planned Colleague exchange program outside the United States are intended to demonstrate our commitment to customers and patients around the world," said Arduini.
