In Safety warnings

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/2006/010 - Baxter Colleague volumetric infusion pumps: all models

Printer friendly version (new window)

Document details:

Type: Medical Device Alert
Series No: MDA/2006/010
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 11
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

Help viewing PDFs:

Page 1

Issued: 15 February 2006 at 11:00
Ref: MDA/2006/010

 

 Tick mark
Immediate action
 
Action
 
Update
 
Information request


 

Device:
Baxter Colleague volumetric infusion pumps: all models.		  

Problem:
There are three problems that can cause the pump to stop and alarm resulting in an interruption to therapy:

  • battery undercharging
  • gearbox wear
  • false air-in-line alarms

There are two further issues with no accompanying alarms:

  • failure of upstream occlusion alarm
  • possibility of under-infusion by up to 19% (typically -5 to -9%, approximately 0.14% of UK pump channels may be greater than -9%).

All these problems present risks of death or serious injury.

 >Page 2

Action by:
All nursing, medical and technical staff using these devices.		  
Action:
Users should be aware of these problems and the actions described overleaf and Baxter's corrective action schedule due to start in April 2006 - see Appendix 2.

 >Pages 2-3

Distributed to:

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

* via CE Bulletin

 >Page 3

Contacts:
Details of manufacturer/supplier contacts and MHRA contacts for technical and clinical aspects.
Change of address or removal from address list for CSCI and Healthcare Commission.

 >Page 4

Appendix

 >Pages 5-11 (PDF)



 

Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (Action underway): 22 February 2006
Deadline (Action complete): 29 March 2006


 

Page last modified: 07 February 2008