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MDA/2006/022 - Baxter MiniCap peritoneal dialysis disconnect cap with povidone-iodine

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Document details:

Type: Medical Device Alert
Series No: MDA/2006/022
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 6
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Issued: 22 March 2006 at 11:00
Ref: MDA/2006/022

 

 
Immediate action
Tick mark
Action
 
Update
 
Information request


Device:
Baxter MiniCap peritoneal dialysis disconnect cap with povidone-iodine.		  
Problem:
The povidone-iodine contained in the disconnect caps of these peritoneal dialysis sets has the potential to be a contributing factor to thyroid changes such as hypothyroidism. Patients more likely to be affected are infants and children with smaller peritoneal fill volumes, where higher dialysate concentrations of iodine can result.		  
Action by:
All nursing, medical and technical staff using these devices.		  

Action:
The thyroid function should be monitored in patients with small peritoneal dialysate fill volumes, typically infants and children. In order to minimise iodine exposure, the contents of the peritoneal cavity should be drained to the drain receptacle prior to the initiation of the next fill cycle whenever clinically possible.
Users should be aware of the advice in Baxter's Safety Alert (see appendix in pdf).

  

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.		  

 >Page 2
Appendix:
Baxter Safety Alert.

  >Pages 4-6


Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 29 March 2006
Deadline (action complete): 03 May 2006


Page last modified: 07 February 2008