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

	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

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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 (1054Kb)

Page last modified: 07 February 2008