TUESDAY, Feb. 13 (HealthDay News) -- The U.S. Food and Drug Administration has announced that Cardinal Health 303 Inc., of San Diego, formerly known as Alaris Medical Systems, Inc., has agreed to stop manufacturing and distributing its Signature Edition infusion pumps due to a design defect.
The defect, known as a "key bounce," can cause the pump to wrongly interpret key strokes and over-infuse medications as a result. Cardinal 303 and three of its top executives signed a decree for condemnation and permanent injunction and will only resume manufacture of the infusion pumps when it can comply with current good manufacturing practice and quality system requirements.
The company will be allowed to repair and service pumps already in the market but must submit a corrective action plan to the FDA for these devices as well as undertake the process of correcting its manufacture process.
"After corrective actions under the decree are completed and Cardinal 303 has been allowed to resume manufacturing and distribution, the firm will hire an independent auditor to conduct audit inspections of its Signature Edition infusion pump facilities at least once a year for no less than four years. Results of these audit inspections will be reported directly to FDA," according to a statement from the FDA.
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