A Medical Device Daily

At the request of the FDA, the U.S. District Court for the Southern District of California issued a warrant for seizure of Alaris (San Diego) Signature Edition Gold infusion pumps, model numbers 7130, 7131, 7230 and 7231.

The pumps are manufactured by Cardinal Health Care 303 , a subsidiary of Cardinal Healthcare (Dublin, Ohio), and the seizure occurred Aug. 25.

The FDA said the seized infusion pumps have a design defect called “key bounce” that may cause potential over-infusion of medications. This seizure was intended to ensure that infusion pumps located at Alaris' manufacturing facility are not distributed unless the problem is corrected.

Infusion pumps are electronic devices intended for controlled delivery of intravenous solutions and medications to patients. Key bounce occurs when a number pressed on the pump registers twice although the operator only pressed the key once. If a key bounce occurs and is not detected during programming verification, it may result in an infusion rate at least 10 times the intended infusion rate.

For example, if an infusion rate is intended to be entered as 4.8 milliliters per hour and the key bounce occurs when the 4 is pressed, the actual rate registered will be 44.8 milliliters per hour. If not detected during programming verification, key bounce events may result in serious patient harm or death.

FDA inspections revealed that Alaris failed to follow FDA's medical device manufacturing regulations. The infusion pumps were seized by the U.S. Marshals Service at Alaris' manufacturing facility in San Diego. The seized devices were valued at more than $1.8 million. Alaris has distributed these products nationally and internationally. No products were seized from healthcare facilities or individual users, and there are no plans to do so.

The FDA noted it previously issued Alaris warning letters in August 1998 and October 1999 outlining the violations and that it gave the company several opportunities to correct the violations, but it failed to take appropriate actions.

In an Aug. 15 recall letter, Alaris informed customers that it will provide a warning label for the pumps and a permanent correction for the key bounce problem once it is available. In the letter, Alaris also provided recommendations to pump users on steps they can take to minimize key entry errors until the problem can be corrected.

In a release of its own, Cardinal reported that it has suspended production, sales, repairs and installations of its Alaris SE (formerly the Signature Edition Infusion Pump) infusion pump after about 1,300 units were seized by the FDA.

On Aug. 15, Cardinal said it had initiated a voluntary corrective action of the product as the result of information indicating that a sensitive keypad posed a risk of “key bounce” and could lead to overinfusing patients.

As part of the field corrective action, the company said it had sent letters and warning labels to its customers and is currently testing a modification that reduces sensitivity of the keypad. This modification will need to be validated on the product and approved by the FDA.

These actions do not require the return of products currently in use by customers.

“The safety of patients is our primary concern and we are cooperating with the FDA as we work to educate customers about the risk of key bounce and make modifications to our product that will help eliminate the risk,” said David Schlotterbeck, CEO of Pharmaceutical and Medical Products for Cardinal Health.

The company said it would resume manufacturing and distribution of the Alaris SE infusion pumps pending resolution of the issue with the FDA.

Cardinal said there have been about 140,000 Alaris SE infusion pumps distributed worldwide during the past 12 years and the product line currently represents less than 1% of annual revenue for Cardinal Health's Clinical Technologies and Services segment.