Cardinal Health announced that it stopped production of four Alaris drug infusion pumps. The announcement came after the FDA requested that U.S. marshals confiscate 1,300 devices out of the company’s San Diego facility on Friday. The Alaris pumps, which are used to regulate the delivery of intravenous drugs to patients, have been linked to at least two deaths due to an oversensitive keypad.
According to the FDA the defect in the keypad causes “key bounce,†which occurs when a number entered into the keypad is recorded more than once. If the intended dose is 3.5 milliliters per hour, the defective keyboard could actually enter 33.5 milliliters into the pump, and can cause a serious overdose.
Surprisingly, the FDA has not issued a recall of the defective pumps that are already in hospitals. Analysts have estimated that there have been approximately 140,000 Alaris SE infusion pumps distributed worldwide over the last 12 years. Since many hospitals still use the Alaris pumps, millions of hospital patients are still at risk of overdose.
Cardinal Health, which owns Alaris, claims there have been no deaths associated with the recalled pumps. But the FDA said the devices have been associated with at least two patient deaths. In one death, a patient given too much of the blood thinner heparin died in January 1999. The other incident occurred in February 2005, when a 16-day-old baby died after receiving 44.8 milliliters of intravenous nutrition an hour instead of the prescribed 4.8 milliliters through an Alaris pump.
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