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: 15 February 2006 at 11:00 |
Ref: MDA/2006/010
|
|
Immediate action |
|
|
Action |
|
|
Update |
|
|
Information request |
| Device: Baxter Colleague volumetric infusion pumps: all models. |
|||||||||
|
Problem:
There are two further issues with no accompanying alarms:
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:
* 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
|
MDA/2006/010 - Baxter Colleague volumetric infusion pumps: all models. 
