08/31/06
At the request of the FDA, the US District Court for the Southern District of California issued a warrant for the seizure of Alaris Signature Edition Gold infusion pumps, model numbers 7130, 7131, 7230, and 7231. Cardinal Health Care 303 Inc manufactured the pumps. The seizure occurred August 25.
This seizure was intended to ensure that infusion pumps located at Alaris’ manufacturing facility are not distributed unless the problem is corrected. The seized infusion pumps have a design defect called “key bounce” that may cause over-infusion of medications. If not detected during programming verification, key bounce events may result in serious patient harm or death.
FDA inspections revealed that Alaris failed to follow FDA’s medical device manufacturing regulations. US Marshals Service seized the pumps at Alaris’ manufacturing facility in San Diego, Calif. The devices—valued at more than an estimated 1.8 million dollars—have been distributed nationally and internationally. No products were seized from health care facilities or individual users, and there are no plans to do so.
Alaris was issued warning letters by FDA in August 1998 and October 1999 outlining the violations and was given opportunities to correct the violations, but Alaris failed to take appropriate actions.
In an August 15 recall letter, Alaris informed customers that it would provide a warning label for the pumps and a permanent correction for the key bounce problem once it is available.
