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MDA/2005/050 - Baxter Healthcare Colleague volumetric infusion pumps product code 2M8151K, FKM8151 and 2M8153K - Recall.

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Document details:

Type: Medical Device Alert
Series No: MDA/2005/050
Audience: Healthcare professionals
Published:
Format:
Size: A4
Pages: 7
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Ref. MDA/2005/050
Issued: 30 August 2005

IMMEDIATE ACTION  
ACTION Tick mark
UPDATE  
INFORMATION REQUEST  


  Further Information
DEVICE:
Baxter Healthcare Colleague volumetric infusion pumps product code 2M8151K, FKM8151 and 2M8151K - Recall.		  
PROBLEM:
Due to a problem with a clocking circuit, the internal communications in some Colleague pumps can be disrupted. If the internal communications are disrupted, the pumps are designed to alarm, stop infusing and display a failure code. This could interrupt critical therapy.

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ACTION BY:
All nursing and medical personnel using these devices.		  

ACTION:
Baxter is asking Trusts to take out of service Colleague pumps that have stopped and alarmed showing any of the following failure codes:

402, 403, 532, 533, 534, 535, 599, 702, 703, 704, 720, 804:21, 804:22, 804:24, 804:29, 804:34, 804:52, 804:54, 804:58 and 12:303:xxx:006.

Follow the advice in Baxter's Recall letter originally distributed 25 July 2005. (See appendix).

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DISTRIBUTED to:

NHS Trusts (England) - Chief Executives*
Commission for Social Care Inspection (CSCI) - Headquarters
Healthcare Commission (CHAI) - Headquarters
Primary Care Trusts (England) - Chief Executives*
Health Protection Agency (England) - Directors

* via CE Bulletin

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CONTACTS:
Details of manufacturer, MHRA contacts for technical and clinical aspects.
Change of address or removal from address list for CSCI and Healthcare Commission.

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Page last modified: 07 February 2008