Class 1 Recall: Baxter Healthcare Corp. COLLEAGUE® and COLLEAGUE® CX Volumetric Infusion Pumps

Date Recall
Initiated:

December 13, 2005

See also:

• September 19, 2005 Recall for Baxter COLLEAGUE® Volumetric Infusion Pumps
• July 19, 2005 Recall for Baxter COLLEAGUE® Volumetric Infusion Pumps

Product:

All models of Baxter Healthcare Corp. COLLEAGUE® Volumetric Infusion Pumps.
Affected Models are: 2M8151, 2M8151R, 2M8161, 2M8161R, 2M8153, 2M8153R, 2M8163, and 2M8163R.

Use:

These electronic infusion pumps are used to give controlled amounts of medications or other fluids to patients through an intravenous (IV), intra-arterial (IA), epidural or other direct line into the bloodstream.

Recalling Firm:

Baxter Healthcare Corporation
Rt. 120 & Wilson Road
Round Lake, IL 60073

Reason for Recall:

Battery Undercharging: The pump’s battery charge level indicator may overstate the battery power level and shut down when operating on battery power if not charged for a full 12 hours following a “low battery” alarm.
False Air Detection Alarms: If the pump’s tubing is stretched or pulled, the pump’s sensors may misinterpret this tension as air in the line, resulting in a false alarm and shutting down the pump.
Gearbox Wear: Worn parts in the pump’s motor can cause the pump to shut down and interrupt therapy.
Under-infusion: If there is an obstruction during tube-loading, the upper jaw of the pump head can be moved out of alignment, resulting in insufficient fluid delivery.
Non-detection of upstream occlusion: Improperly spiked bags, use of a source container which has had all air removed, improper venting of the container, and an unopened air vent above the burette chamber may result in the pump not detecting an upstream occlusion.

Any of these failures may delay or interrupt therapy, which could result in a life-threatening situation for patients, depending on the type of therapy being administered.

Public Contact:

Center for One Baxter
Baxter Healthcare Corporation
1 Deerfield Parkway
Deerfield, IL 60015
800-422-9837

FDA District:

Chicago

FDA Comments:

• FDA has issued previous recall notices for the COLLEAGUE® Volumetric Infusion Pumps. Information explaining the reason for these recalls can be found on the Agency’s web site:
  • September 19, 2005 Recall for Baxter COLLEAGUE® Volumetric Infusion Pumps
  • July 19, 2005 Recall for Baxter COLLEAGUE® Volumetric Infusion Pumps

• Baxter sent a December 13, 2005 Urgent Device Correction Notice to all COLLEAGUE® customers alerting them to the additional problems with the pump identified in this notice. The letter included instructions for reducing the occurrence of these potential problems, and included a copy of the Battery Usage Guide, Infusion Management Guide, and the March 17, 2005 Buretrol Set Urgent Device Correction letter to be distributed to all users of the Colleague pump.

• Baxter also informed customers that they would be notified when the new release of the COLLEAGUE® Volumetric Infusion Pump Operator’s Manual is available.

• COLLEAGUE® customers with questions may contact Baxter’s Medication Delivery Services at 1-800-843-7867.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

Consumers with questions may contact the company at 800-422-9837, or visit Baxter’s website.