by
Keith Loria, Reporter | September 15, 2010
On April 30, the FDA sent a letter to Baxter ordering the company to recall and destroy all of its Colleague Volumetric infusion pumps, citing its “long-standing failure to correct many serious problems with the pumps.” Baxter has worked cooperatively with the FDA and is providing refunds or replacing the pumps at no cost to customers.
Sigma Spectrum Infusion
System, exclusively distributed
by Baxter.
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Under the FDA’s order, Baxter is responsible for recalling as many as 200,000 CVIP currently in use in the United States and must complete the process by July 14, 2012.
“Baxter’s goal is to support a seamless transition by providing options that best address the needs of our hospital customers and minimize disruption to the delivery of patient care,” Patterson says. “The 24-month timeframe allows customers to continue using the Colleague pump while transitioning to either the Spectrum pump or other FDA-cleared devices. Baxter is working with Sigma to increase production capacity of the Spectrum pump in order to meet the anticipated demand for this device.”
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 it fixed manufacturing deficiencies and brought the pumps into compliance with the law.
Patterson says that the company is excited about resolving its issues and getting out of the consent decree it has had with the FDA as it feels companies such as Hospira, CareFusion and B. Braun have expanded their role in the sector at Baxter’s expense.
“Finally, with the resolution that was announced, I think we will be close to having an end to this oversight we have had for five years,” he says. “It’s an incredible relief to Baxter employees to see the end, so-to-speak, of the legal issues. The hard work they have put in, the incredible talent and improvements in quality systems that will now be evidenced in the products that they have worked on is exciting to Baxter.”
Decision time
Many hospitals are looking to move over to smart pumps now, but making a change to that technology is a major undertaking and requires coordinated preparation.
