Baxter International Inc. Thursday settled U.S. Justice Department allegations that two of its popular medication delivery pumps were flawed and violated federal law.
In a 30-page agreement approved Thursday by U.S. District Judge Wayne Anderson in Chicago, the Deerfield-based medical products maker said it would stop manufacturing and distributing the pumps until the company fixes problems that appear to have caused some of the devices to stop operating.
The devices were identified as the Colleague Volumetric Infusion Pump and the Syndeo PCA Syringe Pump, both made in Singapore by Baxter.
Baxter said it will record a second quarter charge of up to $70 million, or 11 cents a share, to cover “remediation costs.”
The settlement resolves an FDA suit filed in October after federal agents seized more than 7,000 devices, mostly pumps, distributed from two of Baxter’s suburban facilities. Defects in the pumps may have led to eight deaths and 16 serious injuries, the company and the FDA have said.
“Infusion pumps deliver life-saving drugs and nutrition to thousands of critically ill patients. But if they don’t work properly patients are put at risk,” said Dr. Daniel Schultz, director of the FDA’s Center for Devices and Radiological Health. .”
Under the consent decree Baxter agreed to take all necessary measures to ensure compliance with good manufacturing and quality system requirements. It has hired an independent consultant to conduct inspections of its pump facilities and certify that corrections have been made.
“Patient well-being and safety are Baxter’s top priorities,” said Baxter Chairman and Chief Executive Robert Parkinson Jr. “The agreement we’ve reached with FDA provides a clear path to resolving Colleague and Syndeo issues, so that we may continue to serve patients and medical professionals by delivering the quality, reliability and innovation they expect from Baxter.”
Colleague generated annual sales of about $170 million. Baxter generates about $10 billion in annual sales.
There are more than 200,000 Colleague pumps in use in the U.S. and about 50,000 in use outside the country, mostly in Canada, Europe and Australia. Baxter will continue to provide routine maintenance service or replace parts for infusion pumps that were already in customers’ possession before Oct. 12, 2005.
———-
bjapsen@tribune.com
