Baxter given the go-ahead for banned infusion pump
Healthcare the go ahead for a modified version of the company's
Colleague volumetric infusion pump that was the subject of FDA
recalls and seizures in 2005 following patient deaths and injuries.
The FDA initiated a Class I recall - the most serious category of recall, in which there is a reasonable chance that the product will cause injury or death - after a series of flaws were found in the pump, thought to be responsible for at least six reports of serious injury and three deaths. The pumps had a number of problems, including confusing display screens, swollen batteries and other defects that could result in the pumps shutting down or under-/over-delivering medication and fluids to patients. The Colleague device was one of the most commonly used volumetric pumps in the US when US marshals seized all pumps from Baxter's Illinois warehouses in October 2005 at the request of the FDA. Baxter had issued several urgent safety notices and recalls for the Colleague pumps before initiating a worldwide recall of all models of the product. In June 2006 the company signed a consent decree with the FDA agreeing to correct manufacturing deficiencies as well as ceasing manufacture and distribution of the pumps. In this latest step, Baxter submitted to the FDA a pre-market submission for the modified pump and announced that it had received clearance from the agency this week. "The company is preparing to modify pumps currently in the market and will soon submit manufacturing and service documentation to FDA in advance of deploying upgrades to US Colleague infusion pumps," a statement from the company read. Moves outlined in the company's pre-market submission to the FDA include detailed electromagnetic testing of the pumps, redesign of the battery protection circuit, a human factors evaluation, improved interface and a rewritten user manual. In addition to these measures, a requirement of the consent decree signed in June 2006 demanded that should Baxter be allowed to resume manufacture and distribution of the pumps, the firm would be required to hire an independent auditor to conduct inspections of the domestic infusion pump facilities at least once a year for a minimum of four years. "Infusion pumps deliver life-saving drugs and nutrition to thousands of critically ill patients. But if they don't work properly, patients are put at risk," said Daniel Schultz, director of the FDA's Center for Devices and Radiological Health. "Baxter has clearly had significant problems with some of its infusion pumps…FDA's goal is to see that the necessary corrections are made, that the public health is protected and that users have access to safe and effective pumps." Baxter has already completed deployment of upgrades in key markets outside the US, with around 58,000 pumps in 55 countries already upgraded and sales activities resumed. There are currently over 200,000 pumps being used in hospitals and other healthcare settings in the US. "Resolving issues with the Colleague infusion pump has been Baxter's top priority," said Baxter corporate vice president and president of the medication delivery business, Peter Arduini. "Baxter remains committed to our infusion systems customers and will continue to invest in this business to enhance the delivery of life-saving medications."