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MDA/2007/012 - Intensive care continuous renal replacement system: Gambro Prismaflex Model Number 6023014700 - All serial numbers

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Document details:

Type: Medical Device Alert
Series No: MDA/2007/012
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 5
Price:
ISBN/ISSN:
Author:
Copyright: Crown
   

Page 1

Issued: 06 February 2007 at 10:00
Ref: MDA/2007/012

 

 
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Information request


Device:
Intensive care continuous renal replacement system: Gambro Prismaflex Model Number 6023014700. All serial numbers..		  
Problem:
There have been reports of discrepancies between the flow rate set by the user (as displayed on the ‘Enter Flow Rate’ screen) and the resulting flow rate (as displayed in the ‘Status’ screen).
A software upgrade was issued to correct this flow rate problem, however there is still a risk of flow rate discrepancies occurring after the software is upgraded.
Gambro is also aware of a number of other problems that can affect the operation of this equipment and are implementing a number of hardware and software corrective actions.		  

>Page 2

Action by:
Intensive care staff, renal physicians, maintenance and engineering staff.		  

Action:

Ensure systems are in place for users to:

  • be aware that the Prismaflex system may be affected by flow discrepancies, requiring vigilance whilst using this equipment
  • check that the displayed flow rate value is the set flow rate. If a problem is found, follow the manufacturer’s instructions, as described in the Appendix.
  • report problems, such as discrepancies in flow rate, whilst using the Prismaflex system to the MHRA Adverse Incident Centre.

 

>Page 2

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.

>Page 3

Appendix:
Manufacturer’s advisory notice.

>Pages 4-5



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 26 February 2007
Deadline (action complete): 19 March 2007


Page last modified: 06 February 2007