Alaris Infusion Pumps

Some Alaris Signature Edition (also called Alaris SE) infusion pumps have a design defect that can cause over-infusion of medications into a patient's bloodstream. Over-infusion can potentially result in serious harm or death to the patient.

The Alaris infusion pump is programmed with a touch-sensitive keypad. The keypad sometimes registers a number twice when it has been pressed only once ("key bounce"). For example, if a medication is intended to infuse at a rate of 4 milliliters per hour, key bounce might cause the number "4" to register as "44." Thus the pump would deliver more than 10 times the intended amount of medication.

Alaris has violated FDA's quality system regulations several times. A February 2006 inspection found significant manufacturing and quality violations for this product line. After FDA laboratories confirmed the key bounce problem, FDA requested the seizure of all violative products at the firm's facility. This seizure was limited to the pumps that were at the site and did not affect the distribution of any units that were confirmed not to have the key bounce problem.

The FDA has ordered a seizure of affected Alaris pumps.  The suspended pumps are Cardinal's Alaris Signature Edition Gold infusion pumps, model numbers 7130, 7131, 7230 and 7231.

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