Device Recall Colleague 3 and Colleague 3 CX Volumetric Infusion Pumps 의 리콜

Recall

32678

Class 1

Z-1060-05

2005-07-20

2005-08-10

Terminated

United States

2011-06-01

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40540

A hardware problem can cause internal communications errors which halt therapies, generate alarms and communication failure codes.

Baxter sent the 7/20/05 Urgent Product Recall letter to all Colleague Infusion Pump customers, to the attention of the Director of Nursing and the Biomedical Engineer, via overnight delivery to alert them of a patient death which may have been associated with an electronic failure resulting from a design issue with the pump, and listed failure codes 402, 403, 532, 533, 534, 535, 702, 703, 704, 720, 804:22, 804:24, 804:29, 804:34, 804:52, 804:54, 804:58 and 12:303:xxx:0006 that may be related to the electronic failure. The users were advised to have a contingency plan to mitigate any disruptions of infusions of life sustaining drugs if the listed failure codes occur, and to take the pump out of service. They were also requested to review the event history of their pumps and take any pump with a previous history of the listed failures out of service. The accounts were also advised that all pumps processed through Baxter's service operations will be checked for the listed failure codes, and if a pump is found to have any of the codes in its event history, it will not be returned until a corrective action has been implemented. Any questions were directed to Baxter's Medication Delivery Services at 1-800-843-7867.