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MDA/2007/064 - Fluid warming set: Level 1 normothermic IV fluid administration and irrigation sets - D/DI and IR/IRI series manufactured by Smiths Medical

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Document details:

Type: Medical Device Alert
Series No: MDA/2007/064
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 10
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Issued: 15 August 2007 at 15:00
Ref: MDA/2007/064


Tick mark
Immediate action
 
Action
 
Update
 
Information request


Device:
Fluid warming set: Level 1 normothermic IV fluid administration and irrigation sets - D/DI and IR/IRI series manufactured by Smiths Medical.

>Page 2

Problem:
Small holes have been found in the inner lumen (aluminium tube) of some sets which can allow leakage of the heating fluid into the infusate with the potential for contamination.

>Page 2

Action by:
All those involved in the use of these devices including perfusionists, operating department practitioners, theatre staff/managers and anaesthetists.		  

Action:

  • Identify products with an expiry date on or prior to July 2011 and not labelled “Helium Tested”. Catalogue numbers can be found in the ‘Device’ section overleaf.
  • Carry out pre-use checks on these devices as recommended by the manufacturer and detailed in the customer letter which can be found appended to this alert.
  • If the pre-use checks cannot be followed, use the alternative methods of fluid warming, also detailed in the Appendix (in pdf only), until replacement stock can be provided by the manufacturer.
  • Return the customer reply letter to the manufacturer with your indicated preference of action.
  

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

Appendix:
Smiths Medical customer letter, reply form, pre-use instructions and alternative methods of
fluid warming (in pdf only).

>Pages 4-10



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 30 August 2007
Deadline (action complete): 13 September 2007


Page last modified: 15 August 2007