A Medical Device Daily
Baxter Healthcare (Deerfield, Illinois) said it has acknowledged a recall classification by the FDA for drug infusion pumps to comply with the regulatory process to eventually get the devices back on the market.
Last Thursday, Baxter said the FDA classified a letter it sent to customers in December 2005 as a Class I recall – the FDA's most serious recall, which is issued when a product poses the potential for serious injury or death.
The company sent that letter to update information on problems experienced with its Colleague volumetric infusion pump.
The letter cited problems of battery undercharging, false alarms, gearbox wear, underinfusion of drugs, and instances where clogs in the device were not detected.
Baxter said the FDA recall does not require the return of devices on the market. The company said it received a report of one death possibly from an undercharged battery, and one death that may be from interrupted therapy due to a false alarm.
Baxter said it has filed a 510(k) marketing clearance application with the FDA that addresses the problems in the December letter, with the hope of reintroducing the pumps back onto the market.
Problems with the pumps began to surface last year when the company alerted customers that battery problems with the pumps may have caused four deaths and 10 serious injuries, and stopped shipments of the pumps. The company started to correct difficulties with the pump, and issued another product alert in March after reports of software glitches that may have contributed to three deaths and six serious injuries. The FDA responded by classifying the actions as Class I recalls in September and July, respectively.
Then, in October, the FDA seized nearly 7,000 infusion pumps from Baxter's inventory after the agency had determined the company had not dealt properly with product recalls.
In all the recall classifications, returning devices to Baxter has not been required.
The company said there are about 250,000 Colleague infusion pumps currently in use, including 206,000 distributed in the U.S.
In 2005, the company established a reserve for remediation costs associated with the Colleague pump, including those identified in the Dec. 13 customer notification.