Cardinal Halts Sales of Flawed Pump

Cardinal Health Inc. said Monday it suspended production and sales of a medical pump after the Food and Drug Administration seized 1,300 of the devices because of what the agency called a design defect.

The FDA said the Alaris SE drug infusion pumps were seized Friday at a warehouse in San Diego to ensure that they were not sold unless the problem was corrected.

The infusion pumps, mainly used by hospitals, are electronic devices intended for controlled delivery of intravenous solutions and medications.

On Aug. 15, the medical supplier warned that sensitive keypads on the pumps could present the risk of “key bounce,” which could accidentally overdose patients. Modifications to resolve the overly sensitive keypads were sent to customers.

According to the FDA, key bounce occurs when a pressed number registers twice even though the operator pressed the key once. If not detected during programming verification, key bounces could harm or kill patients, the FDA said.

The FDA and the company said the pumps can be safely used as long as proper verification procedures are followed. Cardinal said customers were not required to return products already in use.

Cardinal, based in suburban Columbus, Ohio, plans to submit a manufacturing step to the FDA to correct the problem and will resume sales after resolving the issue.

Cardinal acquired Alaris in 2004. The FDA said Alaris had failed to follow medical device manufacturing regulations and received warning letters from the agency in August 1998 and October 1999. Alaris was given opportunities to correct the violations but failed to do so, the FDA said.