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MDA/2007/027 - Haemodialysis machine: Integra manufactured by Gambro

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Document details:

Type: Medical Device Alert
Series No: MDA/2007/027
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 3
Price:
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Issued: 21 March 2007 at 15:30
Ref: MDA/2007/027


 

 Tick mark
Immediate action
 
Action
 
Update
 Tick mark 
Information request


Device:
Haemodialysis machine: Integra manufactured by Gambro.		  
Problem:
Events of insufficient fluid removal have been recorded during ultrafiltration.

 >Page 2

Action by:
All renal unit staff and renal technicians.		  

Action:

  1. Ensure systems are in place for users to be aware that the Integra may not remove the correct amounts of fluid as programmed.
  2. If inadequate fluid removal episodes are encountered, contact Gambro to arrange for initial maintenance of the devices (which includes flow meter replacement) as well as increased frequency of follow-up visits.
  3. Check that all machines are operating on software version 2.19.4. If not, contact Gambro for the software upgrade.
  4. If problems of insufficient fluid removal are experienced whilst using the Integra system, report to the MHRA (Adverse Incident Centre).
 

Distributed to:

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

* 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



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 11 April 2007
Deadline (action complete): 2 May 2007

 

Page last modified: 21 March 2007