Enter a keyword or phrase to search all pages in this section:


Advanced search

Archive:

Looking for a previously published document in this section?

MDA/2008/011 - Automated peritoneal dialysis systems. Homechoice/Homechoice Pro by Baxter Healthcare Ltd

Document details:

Type: Medical Device Alert
Series No: MDA/2008/011
Audience: Healthcare Professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 5
Price: Free
ISBN/ISSN:
Author:
Copyright: Crown
   

Help viewing PDFs:

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: 3 March 2008 at 14:30
Ref: MDA/2008/011

  

 
Immediate action
Tick mark
Action
 
Update
 
Information request
 
Device:
Automated peritoneal dialysis systems.
Homechoice/Homechoice Pro (Baxter Healthcare Ltd).

› Page 2

Problem:
A potential for the unrecorded delivery of infused fluid during treatment.
 
Action by:
Peritoneal dialysis staff, renal units, district nurses.
 

Action:
Ensure that:

  • all users and home dialysis patients are aware of the information listed in the attached manufacturer’s advisory notice
  • Baxter is made aware of Homechoice peritoneal dialysis devices used by neonates and paediatric patients so that the exchange of these devices can be prioritised.
 

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 and MHRA contacts for technical and clinical aspects.
Change of address or removal from address list for Healthcare Commission.

› Pages 2-3

Appendix:
Manufacturer’s advisory notice (in pdf only).

› Pages 4-5 

 
 
Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 31 March 2008
Deadline (action complete): 28 April 2008

Page last modified: 04 March 2008