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MDA/2008/024 - Invasive blood pressure monitoring sets: LogiCal, NovaTrans and TranStar models with trigger flush device manufactured by Smiths Medical

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Document details:

Type: Medical Device Alert
Series No: MDA/2008/024
Audience: Healthcare Professionals
Published:
Format: Electronic & Paper
Size: A4
Pages: 4
Price: Free
ISBN/ISSN: n/a
Author:
Copyright: Crown
   

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Page 1

Issued: 07 April 2008 at 14:00
Ref: MDA/2008/024
 Tick mark
Immediate action
 
Action
 
Update
 Tick mark
Information request


Device:
Invasive blood pressure monitoring sets: LogiCal, NovaTrans and TranStar models with trigger flush device manufactured by Smiths Medical. Manufactured from October 2007 to February 2008 inclusive.

› Page 2
Problem:
An error in the manufacture of the trigger flush device can lead to over-infusion of fluid. This may also cause falsely elevated blood pressure measurements.		  
Action by:
All medical and nursing staff. In particular theatre staff/managers and intensive care staff.		  

Action:

  • Identify product codes of affected devices (see Device section on next page).
  • Check for excessive flow rate (see Action section on next page).
  • Malfunctioning devices should be retained and reported to the MHRA.

› Page 2

Distributed to:

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

* via CE Bulletin

  

› Page 3
Contacts:
Details of manufacturer contacts and MHRA contacts for technical and clinical aspects. Change of address or removal from address list for Healthcare Commission.

› Page 3-4


Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 21 April 2008
Deadline (action complete): 28 April 2008


Page last modified: 29 May 2008