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: 20 December 2007 at 14:30 |
Ref: MDA/2007/100
|
|
|
Immediate action |
|
Action |
|
|
Update |
|
|
Information request |
| Device: Volumetric infusion pump. Smiths Medical (Graseby) 500 and 505 volumetric infusion pumps – all models. |
|||||||||
| Problem: There is the possibility of delivering an unintended 1.7 ml bolus if the pump door is opened and then immediately closed following a stoppage of the pump. |
>Page 2 |
||||||||
| Action by: Users of these pumps. |
|||||||||
| Action: To prevent unwanted boluses being delivered to a patient, always wait for a count of at least six seconds after opening the pump door before closing it again. |
|||||||||
|
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 CSCI and Healthcare Commission. |
>Pages 2-3 |
||||||||
| Appendix: Smiths Medical Customer Information Bulletin |
>Page 4 |
|
Action deadlines for the Safety Alert Broadcast System (SABS)
|
|
|
Deadline (action underway): 21 January 2008
|
Deadline (action complete): 20 February 2008
|
MDA/2007/100 - Volumetric infusion pump. Smiths Medical (Graseby) 500 and 505 volumetric infusion pumps - all models 
