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MDA/2008/045 - Gambro and Hospal blood sets (lot numbers 0806 - 0817)

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Document details:

Type: Medical Device Alert
Series No: MDA/2008/045
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 6
Price: Free
ISBN/ISSN: n/a
Author:
Copyright: Crown
   

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Page 1

Issued: 30 June 2008 15:15
Ref: MDA/2008/045

 

Tick mark
Immediate action
 
Action
 
Update
 
Information request


Device:
Gambro and Hospal blood sets (lot numbers 0806 – 0817).

> Page 2

Problem:
Gambro has identified the potential for a total or partial occlusion of the arterial (red) and/or venous (blue) dialyser connectors of these blood tubing sets. This is due to a moulding defect.		  
Action by:
All renal unit staff.		  

Action:
Verify if product (box/single package) has a green dot on packaging.
If no green dot is present on the blood tubing sets:

  • remove set from packaging and visually inspect sets prior to use to check for occlusions
  • if inspection shows set is occluded DO NOT USE THE SET
  • quarantine device and contact Gambro for replacement.
  

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Distributed to:

NHS trusts in England - Chief Executives*
Healthcare Commission (CHAI) - Headquarters
NHS Boards in Scotland - Chief Executives

* via CE Bulletin

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

> Page 3

Appendix:
Gambro Customer Communication: Follow-up notice.

 PDF Version Only



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 03 July 2008
Deadline (action complete): 21 July 2008


Page last modified: 01 July 2008