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MDA/2007/060 - Enteral feeding pumps: ClearStar model number M771 manufactured by Abbott Nutrition

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Document details:

Type: Medical Device Alert
Series No: MDA/2007/060
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 4
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Issued: 07 August 2007 at 14:30
Ref: MDA/2007/060


 
Immediate action
Tick mark
Action
 
Update
 
Information request


Device:
Enteral feeding pumps: ClearStar model number M771 manufactured by Abbott Nutrition.		  
Problem:
Risk of under-infusion due to cracking/breaking of internal adapter bracket.
The manufacturer has initiated an accelerated service programme of specific serial numbers of these pumps.

>Page 2
Action by:
All staff responsible for prescribing and maintaining enteral feeding devices, particularly dietetic departments and EBME departments.		  

Action:

  • Ensure that all relevant users are aware of the manufacturer's customer notice and follow the advice contained within the notice (see Appendix - in pdf only).
  • Healthcare professionals can log into the Abbott Nutrition website (www.abbottnutritionuk.com (external link)), with their username and password, to check if their pumps are affected as detailed in the attached manufacturer's customer notice.
  • Contact the manufacturer to arrange collection and replacement of affected pumps and chargers.
  

Distributed to:

NHS trusts in England - Chief Executives*
Commission for Social Care Inspection (CSCI) - Headquarters
Healthcare Commission (CHAI) - Headquarters
Primary care trusts in England - Chief Executives*

* via CE Bulletin

>Page 2
Contacts:
Details of manufacturer and MHRA contacts for technical and clinical aspects.
Change of address or removal from address list for CSCI and Healthcare Commission.

 >Pages 2-3
Appendix:
Manufacturer's customer notice (in pdf only).

>Page 4


Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 07 September 2007
Deadline (action complete): 08 October 2007


Page last modified: 07 August 2007