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MDA/2007/044 - Medication cassette reservoir for CADD legacy infusion pumps manufactured by Smiths Medical: model numbers 21-7001-24 and 21-7002-24

Document details:

Type: Medical Device Alert
Series No: MDA/2007/044
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 3
Price: Free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Please note: In October and November 2010, the MHRA moved from its Market Towers address to a new location on Buckingham Palace Road. Please go to the contact us section of the website for updated contact details.

Page 1

Issued: 31 May 2007 at 12:00

Ref: MDA/2007/044

 

Tick mark 
Immediate action
  
Action
 
Update
 
Information request


Device:
Medication cassette reservoir for CADD legacy infusion pumps manufactured by Smiths Medical: model numbers 21-7001-24 and 21-7002-24.

>Page 2 

Problem:
In certain batches of medication cassette reservoirs there was a change of material formulation, to include calcium carbonate.  There have been reports of shifts in pH of medication, discolouration and occlusions, which may or may not be related to this change.  Until further evidence is obtained, it is recommended that these batches are not used.
 

>Page 2  

Action by:
All nursing, medical and technical staff using these devices and pharmacists.

 

Action:

  • Identify and locate medication cassette reservoirs from the affected batches (see overleaf for details).
  • Quarantine the affected medication cassette reservoirs until further evidence is obtained regarding their safety.
  • Contact Smiths Medical for unaffected medication cassette reservoirs. If unaffected medication cassette reservoirs are not available, consider using an alternative infusion system.

 

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.

>Page 3



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 07 June 2007
Deadline (action complete): 21 June 2007


Page last modified: 01 June 2007