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MDA/2007/097 - Infusion pump software for target controlled infusions. Propofol-Schnider model used with Alaris PK pumps manufactured by Cardinal Health

Document details:

Type: Medical Device Alert
Series No: MDA/2007/097
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 6
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Issued: 13 December 2007 at 14:00
Ref: MDA/2007/097

 

 
Immediate action
Tick mark
Action
 
Update
 
Information request


Device:
Infusion pump software for target controlled infusions.
Propofol-Schnider model used with Alaris PK pumps manufactured by Cardinal Health.

>Page 2

Problem:
There are two accepted Schnider models for the delivery of propofol. If the two models are confused there is the possibility to over- or under-anaesthetise obese patients. Users unfamiliar with the Cardinal Health model may over-anaesthetise obese patients at the start of a procedure.

>Page 2

Action by:
Anaesthetists and staff involved in the maintenance of Alaris PK pumps with the propofol-Schnider upgrade kit.
 

Action:
Anaesthetists:

  • Be aware that there are differences between the two Schnider models and know which model you are using.
  • Consider not using ‘effect site targeting’ for obese patients when using the Cardinal Health Schnider model until the software has been updated on these pumps.
  • Maintenance staff should take the actions described overleaf.

>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.

>Pages 2-3

Appendix:
Cardinal Health customer letter (pdf only).
 >Pages 4-6


Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 10 January 2008
Deadline (action complete): 06 March 2008


Page last modified: 13 December 2007