US Marshals Seize Defective Infusion Pumps from Manufacturing Facility
By Amy Teeple
Published on August 28, 2006
Infusion pumps are electronic medical devices that control the delivery of intravenous solutions and medications to patients. The seized pumps contain a design defect called “key bounce" that may cause over-infusion of medications, a process that could lead to serious patient injury or death.
Key bounce occurs when the operator presses a number once, but the pump registers it twice. If key bounce occurs and is not detected during programming verification, it may result in an infusion rate at least 10 times the intended rate.
Alaris Signature Edition Gold infusion pumps, model numbers 7130, 7131, 7230, and 7231, were seized from the facility in order to ensure the pumps were not distributed unless the defect was corrected.
No products were seized from healthcare facilities or individual users. Currently there are no plans to do so. A previously issued recall letter informed Alaris customers that the company will provide a warning label for the pumps as well as a permanent correction for the key bounce problem once it is available. The letter also informed customers how to minimize key bounce errors until the problem can be corrected.
The defective pumps are manufactured by Cardinal Health Care. Alaris has distributed these products nationally and internationally.
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