DEERFIELD, Ill., July 18 /PRNewswire-FirstCall/ -- Baxter Healthcare Corporation announced today that the U.S. Food and Drug Administration (FDA) has classified Baxter’s field corrective action regarding recently manufactured or upgraded COLLEAGUE triple channel infusion pumps as a Class I recall. The company has identified a processing anomaly related to buffer overflow that occurs in specific situations. Baxter has received reports of 16 serious injuries that are associated with this issue at nine U.S. customer accounts.
The error occurs when all three channels are in use and a healthcare professional initiates a user interface-intensive command such as overriding the Guardian dose limit feature, displaying the dose mode window, performing dose calculations or performing running rate changes. Affected devices display an error code, alarm and stop infusing in all three channels. Interruption of life-sustaining therapy could lead to serious injury or death.
All customers with these pumps have been notified and all affected devices have been removed from use. Baxter has provided alternate COLLEAGUE devices, including non-upgraded triple channel and upgraded single channel pumps, to all customers impacted by this recall. The 4,500 affected triple channel pumps were distributed between May 14, 2007 and June 20, 2007.
Baxter’s 200,000 single channel and 75,000 non-upgraded triple channel COLLEAGUE infusion pumps are not affected, and remain in use. Deployment of infusion pump upgrades in the United States continues for COLLEAGUE single channel devices since this error doesn’t occur in single channel pumps.
“Patient safety is our top priority. We identified this error early on in our U.S. remediation process and have taken decisive action to replace these pumps and correct the situation to the satisfaction of our customers,” said Peter J. Arduini, corporate vice president and president of Baxter’s Medication Delivery business. “We are currently evaluating a correction, which we will implement following completion of our testing and FDA review.”
Affected model numbers include: 2M8153, 2M8163 and 2M9163. Customers with questions regarding this notice may contact Baxter at 1-800-843-7867 (1-800-THE-PUMP). Representatives are available Monday through Friday from 7 a.m. to 5 p.m. CDT.
As previously disclosed, the company has not included any financial contribution from the recommercialization of COLLEAGUE infusion pumps in the United States in its financial outlook for 2007.
Baxter International Inc , through its subsidiaries, assists healthcare professionals and their patients with the treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients’ lives. For more information about Baxter, visit www.baxter.com.
This release includes forward-looking statements, including with respect to the company’s prospects for COLLEAGUE, including its recall and remediation. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: additional coordination with and agreement from FDA as to the course of the recall and remediation; final identification and correction of issues with the devices; customer cooperation with and acceptance of remediation and recall plans; and other risks identified (including particularly with respect to COLLEAGUE) in the company’s most recent filing on Form 10-Q and other SEC filings, all of which are available on the company’s web site. The company does not undertake its forward-looking statements.
Baxter Healthcare Corporation
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