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MDA/2008/049 - Smiths Medical Graseby Omnifuse and Omnifuse PCA syringe

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Document details:

Type: Medical Device Alert
Series No: MDA/2008/049
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 7
Price: Free
ISBN/ISSN: n/a
Author:
Copyright: Crown
   

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Page 1

Issued: 2 July 2008 at 15:30
Ref: MDA/2008/049

  

 
Immediate action
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Action
 
Update
 
Information request

 

Device:
Smiths Medical Graseby Omnifuse and Omnifuse PCA syringe pumps

> Page 2

Problem:
Possibility of patients being given an additional/unnecessary infusion when syringes are changed or infusions restarted when using DrugPro software. If the user selects – but does not confirm – a drug protocol from the drug protocol library and then resets/stops the pump, the previously infused volume will not be added to the ‘total volume infused’ display.

> Page 2

Action by:
Clinical and technical staff using or maintaining these pumps.		  
Action:
Identify any affected pumps and follow the advice given in Smiths Medical’s Urgent Field Safety Notice (see Appendix - pdf version onlyPDF file (opens in new window) (384Kb)).		  

Distributed to:

NHS trusts in England - Chief Executives*
Commission for Social Care Inspection (CSCI) - Headquarters
Healthcare Commission (CHAI) - Headquarters
Primary care trusts in England - Chief Executives*
NHS Boards in Scotland - Chief Executives

* 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 CSCI and Healthcare Commission.

> Page 3

Appendix:
Smiths Medical Urgent Field Safety Notice.

 PDF Version onlyPDF file (opens in new window) (384Kb)

 

Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 30 July 2008
Deadline (action complete): 27 August 2008

Page last modified: 02 July 2008