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MDA/2006/021 - Baxter haemodialysis instruments: System 1000 Tina, Aurora and Arena

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Document details:

Type: Medical Device Alert
Series No: MDA/2006/021
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 7
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Issued: 17 March 2006 at 11:00
Ref: MDA/2006/021

 

Tick mark
Immediate action
 
Action
 
Update
 
Information request


Device:
Baxter haemodialysis instruments: System 1000 Tina, Aurora and Arena.		  >Page 2
Problem:
Risk of air entrapment when the tubing is not correctly centred in the venous line clamp as a small portion of the tube can remain open when the clamp closes following activation of the system alarm. It is possible that air may travel to the patient with not further alarm sounding, which can lead to air embolism.		  
Action by:
All those who use these devices (haemodialysis units, nursing, medical, technical staff and home patients).		  

Action:

  • Ensure tubing is placed correctly in accordance with the manufacturer's instructions, as detailed in the attached letter and diagrams (see appendix in pdf).
  • Be aware that an alarm will not be activated if tubing is not correctly placed or inserted in line with instructions.
  • Contact Baxter to arrange for an upgrade.
  

Distributed to:

NHS trusts in England - Chief Executives*
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 Healthcare Commission.		  

 >Pages 2-3

Appendix:
Baxter customer letter.		  

 >Pages 4-7



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 31 March 2006
Deadline (action complete): 16 April 2006


Page last modified: 07 February 2008