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MDA/2006/008 - Intersurgical Clear-Therm heat and moisture exchanging filter (HMEF) with Luer lock port and retainable cap

Document details:

Type: Medical Device Alert
Series No: MDA/2006/008
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: 08 February 2006 at 11:45
Ref: MDA/2006/008

Tick mark
Immediate action
 
Action
 
Update
 
Information request


Device:
Intersurgical Clear-Therm heat and moisture exchanging filter (HMEF) with Luer lock port and retainable cap:
Model number 1841 - batch number 2051272
Model number 1841351 - batch number 2051082
Model number 1841012 - batch number 2051012

 >Page 2

Problem:
The Luer port (used for connection to CO2 monitoring) may be occluded by plastic.
 

 >Page 2

Action by:
Anaesthetists, operating department practitioners, anaesthetic nurses, adult intensive care unit (ICU) and accident and emergency unit (A&E) staff, ambulance staff, respiratory function staff and those responsible for the provision of domiciliary ventilation.
 

Action:

  • Before using a filter from this batch ensure that the Luer port is checked for blockages, either by:
    • attaching a fresh gas supply to one side of the filter, occluding the other side of the filter, removing the Luer cap and feeling for a flow of gas coming out of the Luer port
      or
    • attaching the Luer port to the CO2 monitor prior to use and ensure the monitor does not alarm for occlusion.
  • Return any filters with blockages to Intersurgical to obtain a replacement.
  • If CO2 monitoring is required and no unblocked filters are immediately available then alternative Luer access for CO2 monitoring must be used.
 

Distributed to:

NHS trusts in England - Chief Executives*
Commission for Social Care Inspection (CCSI) - 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



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (Action underway): 22 February 2006
Deadline (Action complete): 08 February  2006


Page last modified: 06 March 2006