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MDA/2008/005 - Hard-shell venous reservoirs and oxygenators used for cardiopulmonary bypass during heart surgery: various manufacturers

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Document details:

Type: Medical Device Alert
Series No: MDA/2008/005
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: 11 February 2008 at 13:30
Ref: MDA/2008/005
 
Immediate action
Tick mark
Action
 
Update
 
Information request

 

Device:
Hard-shell venous reservoirs and oxygenators used for cardiopulmonary bypass during heart surgery: various manufacturers.

> Page 2

Problem:

  1. A bolus of air was forced up the venous line to the heart when a quick-prime line was misconnected to the vent port of a hard-shell venous reservoir.
  2. A problem with a vaporiser prevented the oxygen supply reaching the oxygenator.

> Page 2
Action by:
Clinical Perfusion Scientists and Cardiac Anaesthetists.		  

Action:

  • Incorporate checking of the hard-shell venous reservoir vent port and correct functioning of the oxygen supply in the pre-bypass check procedure.
  • Ensure that a pressure relief valve is always used with hard-shell venous reservoirs.
  • Ensure that the standards of monitoring recommended by the Society of Clinical Perfusion Scientists of Great Britain and Ireland (SOPGBI) are always undertaken for heart lung bypass procedures. (Available on the MHRA website www.mhra.gov.uk)
  • Ensure an alternative oxygen supply is always available for cardiopulmonary bypass (e.g. an oxygen cylinder with appropriate regulator, flow meter and tubing, which must be checked as functioning correctly and containing an adequate supply). NOTE: These actions have been endorsed by the SOPGBI.
  

Distributed to:

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


* via CE Bulletin

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

> Page 2


Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 25 February 2008
Deadline (action complete): 10 March 2008


Page last modified: 11 February 2008