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U.S. Department of Health and Human Services

Class 1 Device Recall Colleague and Colleague CX Volumetric Infusion Pumps

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  Class 1 Device Recall Colleague and Colleague CX Volumetric Infusion Pumps see related information
Date Initiated by Firm July 20, 2005
Date Posted August 10, 2005
Recall Status1 Terminated 3 on June 01, 2011
Recall Number Z-1059-05
Recall Event ID 32678
510(K)Number K041191  
Product Classification infusion pump - Product Code FRN
Product Baxter Colleague Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in Singapore; product codes 2M8151, 2M8151R, 2M8161, 2M8161R
Code Information all serial numbers
Recalling Firm/
Manufacturer		 Baxter Healthcare Corp.
Rt. 120 & Wilson Rd
Round Lake IL 60073
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer Reason
for Recall		 A hardware problem can cause internal communications errors which halt therapies, generate alarms and communication failure codes.
FDA Determined
Cause 2		 Device Design
Action 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.
Quantity in Commerce 152,260 pumps
Distribution Nationwide including Puerto Rico, and internationally to Australia, the Bahamas, Bahrain, Belgium, Brazil, Canada, Colombia, El Salvador, Guatemala, Honduras, Israel, Lebanon, Mexico, New Zealand, Panama, the Philippines, Saudi Arabia, South Africa, Taiwan, Turkey, the United Arab Emirates and teh United Kingdom.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = BAXTER HEALTHCARE CORP.
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