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: 13 December 2007 at 14:00 |
Ref: MDA/2007/097
|
|
|
Immediate action |
|
Action |
|
|
Update |
|
|
Information request |
| Device: Infusion pump software for target controlled infusions. Propofol-Schnider model used with Alaris PK pumps manufactured by Cardinal Health. |
>Page 2 |
||||
| Problem: There are two accepted Schnider models for the delivery of propofol. If the two models are confused there is the possibility to over- or under-anaesthetise obese patients. Users unfamiliar with the Cardinal Health model may over-anaesthetise obese patients at the start of a procedure. |
>Page 2 |
||||
| Action by: Anaesthetists and staff involved in the maintenance of Alaris PK pumps with the propofol-Schnider upgrade kit. |
|||||
|
Action:
|
>Page 2 |
||||
|
Distributed to:
* 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. |
>Pages 2-3 |
||||
| Appendix: Cardinal Health customer letter (pdf only). |
>Pages 4-6 |
|
Action deadlines for the Safety Alert Broadcast System (SABS)
|
|
|
Deadline (action underway): 10 January 2008
|
Deadline (action complete): 06 March 2008
|

