Erin Bradford

February 1, 2007

2 Min Read
Alaris, Baxter Run Afoul of FDA with Infusion Pumps



The Syndeo pump could be reintroduced after Baxter fixes its design problems.

CDRH has historically been suspicious about the reliability of infusion pumps. Incidents with two pump makers in 2006 have reinforced that suspicion and mistrust. Both companies have had repeated run-ins with FDA over various infusion pump issues. However, in 2006, the problems came to a head.

In June, Baxter Healthcare Corp. (Round Lake, IL) signed a consent decree with FDA to stop making and distributing the Colleague Volumetric Infusion Pump and the Syndeo Patient-Controlled Analgesic Syringe Pump. An inspection a year earlier found inadequate management controls over quality system operations and corrective and preventive action procedures, as well as design defects. Then, in September, FDA and Baxter entered into a penalty-free consent decree to resolve GMP problems involving the pumps. Rather than seeking a disgorgement provision, FDA allowed the company to post a $20 million letter of credit, which will be canceled once Baxter reconditions or destroys previously seized devices. Baxter decided to take a $70 million charge for remediation costs associated with the decree, indicating the company's commitment to a resolution.

In mid-December, however, it looked like things might be turning around for Baxter. FDA issued the company conditional approval to fix the pumps, which could clear the way for them to return to market. Although there has been no speculation from Baxter about when the pumps might return, FDA will review the company's regulatory filings. At press time, the agency was expected to reply to Baxter shortly.

Meanwhile, in August, four models of Alaris Signature Edition Gold infusion pumps were seized by U.S. marshals at FDA's request. The pumps have a defect called a key bounce, in which a number pressed once on a keypad may appear twice, leading to possible overinfusion. Warning letters citing this problem had been issued to Alaris in August 1998 and again 14 months later. The company was also “given opportunities to correct the violations, but failed to take appropriate actions,” according to an FDA statement. Alaris issued a product recall letter in August that provided users with ways to minimize key-entry errors until the problem could be corrected, and it suspended the pump's production, sales, repairs, and installations. Alaris is a division of Cardinal Health.

Copyright ©2007 Medical Device & Diagnostic Industry

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