Baxter International Inc. announced the US Food and Drug Administration (FDA) has issued its final order regarding the previously communicated recall of Colleague infusion pumps from the US market. Baxter 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 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. Baxter will also permit US 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 will be providing a transition guide to help customers in replacing Colleague infusion pumps.
This recall is specific to the US market. Outside the US, Baxter has continued to update the Colleague device and will be initiating an additional programme to provide customers with enhanced Colleague devices that contain a new battery management system, as well as further upgrades to software and mechanical systems to improve the product's user interface and performance.
"Our actions in the US as well as our planned Colleague exchange programme outside the United States are intended to demonstrate our commitment to customers and patients around the world," said Arduini.
Baxter introduced the Colleague infusion pump in 1997. The Colleague pump is a large volume infusion pump used to deliver medication and fluids intravenously to patients throughout a broad range of clinical settings, most frequently in hospitals. In 2006, Baxter entered into a consent decree with FDA under which the company had been pursuing remediation of the infusion pumps. The Colleague pump can continue to be used safely and effectively in accordance with the operator's manual and additional instructions contained in field corrective actions (customer letters).
Baxter is the exclusive distributor of the Spectrum infusion pump, a next-generation smart pump manufactured by SIGMA International, of which Baxter is a minority owner. Weighing approximately 2.5 pounds and measuring 1/10 the size of many other large volume pumps, the Spectrum pump features technology intended to help reduce pump-related adverse drug events through the use of drug libraries that eliminate the need for clinicians to manually enter commonly used drugs and dosage rates, and features a wireless connectivity option. Spectrum, which is currently available in the US, uses standard, low-cost intravenous administration sets (the tubing that delivers fluid through the infusion pump to the patient) such as those manufactured by Baxter.