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MDA/2008/036 - Invasive blood pressure monitoring sets: LogiCal, NovaTrans and TranStar models with trigger flush device

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Document details:

Type: Medical Device Alert
Series No: MDA/2008/036
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 4
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

Page 1

Issued: 03 June 2008 at 11:30
Ref: MDA/2008/036

 

 
Immediate action
Tick mark
Action
Tick mark
Update
 
Information request


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

>Page 2

Problem:
A fault in the manufacture of the trigger flush device can lead to over-infusion of fluid and falsely elevated blood pressure measurements.

Following the publication of MDA/2008/024, the manufacturer has amended its customer field safety notice to clarify the number of drops deemed acceptable.

The manufacturer has informed the MHRA that there is insufficient stock to conduct a total withdrawal of the affected devices.

>Page 2

Action by:
Action by: Theatre, intensive care, high dependency, cardiac catheterisation laboratory and accident and emergency clinical staff.		  

Action:

  • Be aware that this alert supersedes the advice given in MDA/2008/024 (issued on 7 April 2008).
  • 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 quarantined and reported to the MHRA.

>Page 2

Distributed to:

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

* via CE Bulletin

>Page 3

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

>Pages 3-4



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 17 June 2008
Deadline (action complete): 01 July 2008


Page last modified: 03 June 2008