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MDA/2007/015 - Fluid warming administration set: Smiths Medical Level 1® normothermic IV fluid administration set

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Document details:

Type: Medical Device Alert
Series No: MDA/2007/015
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 3
Price: Free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Issued: 12 February 2007 at 11:00
Ref: MDA/2007/015


 
Immediate action
Tick mark
Action
 
Update
 
Information request


Device:
Fluid warming administration set: Smiths Medical Level 1® normothermic IV fluid administration set.
Catalogue number DI-60HL (NHS Supply Chain code FFF265).

>Page 2

Problem:
A manufacturing fault in the administration set can prevent appropriate warming of the blood/fluid to be administered, leading to a delay in patient treatment. The manufacturer is recalling specific lots.

 >Page 2

Action by:
Perfusionists, ODPs, theatre staff/managers and anaesthetists.		  

Action:

  • Identify and quarantine affected stock. The lot numbers are listed overleaf.
  • Only use devices from affected lots if an alternative is not available in an emergency situation and only until alternative stock is received.
  • Contact the manufacturer (Tel: 01923 246 434) to organise the return and replacement of affected stock.

>Page 2 

Distributed to:

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

* via CE Bulletin

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

>Page 3



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 12 March 2007
Deadline (action complete): 12 April 2007


Page last modified: 12 February 2007