Baxter Also Notifies Customers of Product Hold on Shipments of COLLEAGUE Infusion Pumps Due to Design Issue

 

DEERFIELD, Ill., July 21, 2005 – Baxter Healthcare Corporation announced that it was notified on July 19, 2005 by the U.S. Food and Drug Administration (FDA) that the agency has classified a March 15, 2005 voluntary notice to customers regarding the company's COLLEAGUE® Volumetric Infusion Pump as a Class I recall.

 

In an Urgent Device Correction notice sent on March 15, Baxter alerted customers worldwide to several user interface and error code issues with the COLLEAGUE® Volumetric Infusion Pump Models 2M8151, 2M8151R, 2M8161, 2M8161R, 2M8153, 2M8153R, 2M8163, 2M8163R that have the potential to disrupt infusions of intravenous therapies to patients. To date, there have been reports of three deaths and six serious injuries that may have been associated with the issues identified in the March 15, 2005 Urgent Device Correction notice.

 

In that March 15 notice, Baxter notified users of the possibility of inadvertently pressing the ON/OFF key instead of the START key when attempting to start an infusion. Further, Baxter notified customers of external communications port failures when users failed to power off the pump when connecting and disconnecting a cable to this port.

 

Baxter is modifying the design of the infusion pump software to reduce the possibility of inadvertently powering off the device when starting an infusion, and to make the pump more fault tolerant when inappropriately using the pump's serial communications port to transmit data to the pump (since COLLEAGUE is designed only for one-way data transfer from the pump to hospital data and monitoring systems).

 

Certain failure codes have occurred infrequently with the COLLEAGUE while the pump is operating. These failure codes are 402 , 403 , 533 , 535 , 599 , 810:04 and 810:11 . If customers experience one of these failure codes, the pump should be taken out of service and inspected by authorized service personnel. In its March 15 notice, Baxter also advised customers to have contingency plans in place should a failure code occur to mitigate against disruption of life-sustaining therapies. COLLEAGUE, like all infusion pumps currently on the market, is designed to detect an anomalous situation, alarm, stop infusing and display a failure code.

 

This notice does not require the return of COLLEAGUE pumps currently in the market. FDA was apprised of this notice in March 2005. Further, Baxter is in the process of developing a number of corrections to address the issues articulated in the notice.

 

In a separate field corrective action letter sent to customers today, the company announced that it is in the process of developing an aggressive action plan to address a design issue with the COLLEAGUE Volumetric Infusion Pump, and the company will voluntarily hold shipments of new COLLEAGUE pumps until the issue is resolved. This design issue involves a clocking circuit contained in the pump that can disrupt internal communications in some devices. While the incidence of this occurring is low, when it does occur, the pump alarms, the infusion stops, and the pump displays a failure code. The FDA also has been informed of this action, and has not yet classified this recall.

 

“We are acting as quickly as possible to correct the issues with the COLLEAGUE pump,” said Robert L. Parkinson, Jr., chairman and chief executive officer. “Quality of our products is our highest priority and we remain committed to enhancing quality systems and processes across all our businesses.”

 

Customers with questions regarding the March 15 or July 20 notices, or FDA's classification of this action, may contact the company at 1-800-843-7867 (1-800-THE-PUMP).

 

Baxter Healthcare Corporation is a subsidiary of Baxter International Inc. (NYSE:BAX). 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, COLLEAGUE® and customer notifications, go to www.baxter.com.

 

This release includes forward-looking statements concerning the COLLEAGUE infusion pump. 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: future actions of regulatory bodies and other governmental authorities, including the FDA and foreign counterparts that could substantially affect the nature or timing of the company's actions; additional product development steps, including software development; product quality or patient safety issues; and the other factors identified 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 to update its forward-looking statements.

March 15 URGENT DEVICE CORRECTION NOTICE TO CUSTOMERS

July 20 URGENT PRODUCT RECALL LETTER FOR CUSTOMERS