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MDA/2006/069 - Wash set bowls used in Sorin Group Dideco Electa and Compact autotransfusion machines

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Document details:

Type: Medical Device Alert
Series No: n/a
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: 15 December 2006 at 10:45
Ref: MDA/2006/069

 

 
Immediate action
Tick mark
Action
 
Update
 
Information request


Device:
Wash set bowls used in Sorin Group Dideco Electa and Compact autotransfusion machines.

>Page 2

Problem:
Due to manufacturing problems producing misshapen bowls, there have been reports of difficulties with the insertion of the wash set bowl, which can result in black particles being deposited inside the wash bowl during use. This could lead to the infusion of particles.

>Page 2

Action by:
Perfusionists, ODPs, theatre nurses, anaesthesists and theatre managers.		  

Action:
Stop using affected lots of bowls, unless no alternative is available.

  • If using a bowl from the affected lot, ensure that it can be inserted as described in the instructions overleaf. Sorin also recommends using a blood filter under these circumstances.
  • If any defective bowls are detected, ensure that the manufacturer is contacted to arrange
    collection and replacement of affected stock.
 

>Pages 2-3

Distributed to:

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


* via CE Bulletin

>Page 3

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

>Pages 3-4



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 10 January 2007
Deadline (action complete): 1 February 2007


Page last modified: 07 February 2008