A Medical Device Daily
Cardinal Health (Dublin, Ohio) reported reaching an agreement with the FDA on a consent decree regarding its Alaris SE line of infusion pumps.
The agreement, subject to approval by the U.S. District Court for the Southern District of California, outlines the process Cardinal will follow to resume the manufacture and sale of its Alaris SE pumps (formerly the Signature Edition Infusion System) in the U.S.
Cardinal last August initiated a voluntary field corrective action of the product as the result of information indicating that a sensitive keypad posed a risk of "key bounce" that could lead to the over-infusion of patients.
On Aug. 28, Cardinal suspended production, sales and repair of the Alaris SE pump after about 1,300 units were seized by the FDA, the value of those pumps set at about $1.8 million (Medical Device Daily, Aug. 29, 2006). These actions did not require the return of products currently in use by customers.
At the time of the seizure, the FDA said it previously had issued Alaris warning letters in August 1998 and October 1999 outlining the violations and that it gave the company several opportunities for correction, but it failed to take appropriate actions.
Servicing of Alaris SE pumps was resumed on Sept. 15, with agreement from the FDA.
The process newly agreed to includes submitting a plan to the FDA outlining corrections for the Alaris SE pumps now in use by customers, submitting a remediation plan for the seized Alaris SE pumps, engaging an independent expert to inspect Alaris SE pump facilities and certify Cardinal's infusion pump operations.
Around 140,000 of the infusion pumps have been distributed worldwide during the past 12 years. Cardinal says that this product line currently represents less than 1% of annual revenue for its Clinical Technologies and Services segment.
As previously reported, the company reserved $13.5 million in 1Q07 for the estimated costs to implement the corrective action plan.