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MDA/2008/012 - Medication cassette reservoir for CADD® Legacy and CADD® Prizm infusion pumps manufactured by Smiths Medical

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Document details:

Type: Medical Device Alert
Series No: MDA/2008/012
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 5
Price: Free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Issued:  5 March 2008 at 14:30
Ref: MDA/2008/012
Tick mark 
Immediate action
 
Action
 
Update
 
Information request


Device:
Medication cassette reservoir for CADD® Legacy and CADD® Prizm infusion pumps manufactured by Smiths Medical. Model numbers 21-7001-24, 21-7002-24 and 21-7100-24. Lot numbers 023X17 to 122X17 inclusive.

› Page 2

Problem:
Manufacturing fault that may allow leakage from, or entry of air into, specific lot numbers of medication cassette reservoir.		  
Action by:
  • All nursing, medical and technical staff using these devices.
  • Pharmacists.
  

Action:

  • Identify and locate medication cassette reservoirs from the affected batches.
  • Quarantine the affected medication cassette reservoirs.
  • Contact Smiths Medical to arrange replacement of affected product.
  • If affected product is already in use, follow the advice in the manufacturer’s customer letter (see Appendix).
  

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*

* 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.

› Pages 2-3

Appendix:
Manufacturer’s customer letter (in pdf only).

› Pages 4-5



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 12 March 2008
Deadline (action complete): 19 March 2008


 

Page last modified: 05 March 2008