FDA Announces Class 1 Recall Baxter Infusion PumpsFeb 6, 2006 | Medscape
The U.S. Food and Drug Administration (FDA) and Baxter Healthcare Corporation have notified healthcare professionals regarding the class 1 recall of all models of Colleague and Colleague CX volumetric infusion pumps.
The electronic devices are subject to multiple malfunctions that can delay or interrupt therapy, resulting in potentially life-threatening situations for patients receiving critical medications and fluids, according to an alert sent Friday from MedWatch, the FDA's safety information and adverse event reporting program.
The action follows 2 previous recall notices in July and September 2005, and an urgent device correction notice issued to consumers in December, alerting them to additional problems with the pumps. These included battery undercharging, false air-detection alarms, gearbox wear, underinfusion, and non-detection of upstream occlusion.
The FDA has determined that the pump's battery charge level indicator may overstate the battery power level and shut down during battery-powered operation if not charged for a full 12 hours following a “low battery” alarm.
In addition, pump sensors may misinterpret a stretch or pull of the tubing as air in the line, resulting in a false alarm and device shut-down. Shut-down may also be caused by worn parts in the motor.
Obstructions during tube loading can cause the upper jaw of the pump head to move out of alignment, resulting in insufficient fluid delivery.
Improperly spiked bags, use of a source container that has had all air removed, improper venting of the container, and an unopened air vent above the burette chamber can result in failure to detect upstream occlusions.
According to an FDA news release, the company has acknowledged the agency’s assessment of corporate-wide quality system and device reporting deficiencies and confirmed its commitment to resolving all issues according to an aggressive timeline.
The infusion pumps are used for the controlled delivery of medications or other fluids to patients through intravenous, intraarterial, epidural, or other direct line into the bloodstream.
Affected devices include models 2M8151, 2M8151R, 2M8161, 2M8161R, 2M8153, 2M8153R, 2M8163, and 2M8163R.
Further information regarding the recall may be obtained online at http://www.baxter.com or by contacting Baxter Healthcare at 1-800-422-9837. Answers to technical questions are available at 1-800-THE-PUMP (800-843-7867).
Healthcare professionals are encouraged to report adverse events related to use of the volumetric infusion pumps to the FDA's MedWatch reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.