On August 25, US Marshals seized a batch of defective infusion pumps in a Cardinal Health Care (the pump’s manufacturer) facility. Apparently, Alaris (part of Cardinal) had failed to follow FDA regulations in the wake of two warning letters issued back in 98 and 99, and continued to manufacture the pumps without fixing the flaw. According to the FDA…
The seized infusion pumps have a design defect called “key bounce” that may cause potential over-infusion of medications. This seizure was intended to ensure that infusion pumps located at Alaris’ manufacturing facility are not distributed unless the problem is corrected.
Key bounce occurs when a number pressed on the pump registers twice although the operator only pressed the key once.
The infusion pumps were seized by the U.S. Marshals Service at Alaris’ manufacturing facility in San Diego, California. The seized devices valued at more than an estimated 1.8 million dollars. Alaris has distributed these products nationally and internationally. No products were seized from healthcare facilities or individual users, and there are no plans to do so.
That last bit shows that the FDA was really looking to drive the point home to Alaris that they need to follow the rules. If this were really a major crisis, they would have seen to it that devices in the field were retired as well. There’s a list of recommendations to users of the devices that basically says to be careful and double check what you entered. (We’d recommend to dial back the caffeine as well – the shakes can’t help with this).
Of course Cardinal/Alaris has no mention of US Marshals in their press release, but they make sure to keep from spooking the investors:
There have been approximately 140,000 Alaris SE infusion pumps distributed worldwide during the past 12 years and the product line currently represents less than 1 percent of annual revenue for Cardinal Health’s Clinical Technologies and Services segment.
More from the FDA…