MDA/2006/025 - Gambro Prisma haemodialysis sets: Prisma M60 Pre Set; Prisma M60 Set; Prisma M100 Pre Set; Prisma M100 Set; Prisma HF1000 Pre Set. Manufactured before the end of October 2005

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Document details:

Type:	Medical Device Alert
Series No:	MDA/2006/025
Audience:	Healthcare professionals
Published:
Format:	Electronic and paper
Size:	A4
Pages:	4
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: 28 April 2006 at 11:00

Ref: MDA/2006/025

	Immediate action
	Action
	Update
	Information request

Device:
Gambro Prisma haemodialysis sets:

Prisma M60 Pre Set
Prisma M60 Set
Prisma M100 Pre Set
Prisma M100 Set
Prisma HF1000 Pre Set

Manufactured before the end of October 2005.

>Page 2

Problem:
During disconnection of the Prisma set from the Prisma haemodialysis system, blood can leak (under pressure) from the access pressure pod due to a manufacturing defect. Further to MDA/2005/066 which related to a limited recall of these devices, the manufacturer has initiated a recall of all batches produced before the end of October 2005.

>Page 2

Action by:
Renal physicians, intensive care consultants and managers of supplies departments.

Action:

Immediately cease use of the affected lots, unless no alternative is available.
Locate and quarantine any products from affected lots if possible.
If only product from affected lots is available, follow the instructions for pre-use checks and disconnection described overleaf.
Ensure that the manufacturer is contacted to arrange collection and replacement of affected stock.

>Pages 2-3

Distributed to:

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

* via CE Bulletin

>Page 3

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 3-4

Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 12 May 2006	Deadline (action complete): 26 May 2006

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MDA/2006/025 - Gambro Prisma haemodialysis sets: Prisma M60 Pre Set; Prisma M60 Set; Prisma M100 Pre Set; Prisma M100 Set; Prisma HF1000 Pre Set. Manufactured before the end of October 2005 (393Kb)

Page last modified: 07 February 2008