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: 17 December 2007 at 11:00 |
Ref: MDA/2007/098
|
|
|
Immediate action |
|
Action |
|
|
Update |
|
|
Information request |
| Device: Enteral feeding pump. Fresenius Kabi Applix Smart pump – all models. |
|||||||||||||
| Problem: Misloaded or incorrectly fitted giving sets can permit free flow of feed to the patient with the possibility of fatal over-feeding. |
>Page 2 |
||||||||||||
| Action by: All medical, nursing and allied health professional staff involved with the management and use of these and other enteral feeding pumps. |
|||||||||||||
| Action: Ensure that the giving set is correctly fitted in the lower tube guide and is slightly stretched in a straight line. See appendix for manufacturer’s instructions for use (in pdf only). |
>Page 2 |
||||||||||||
|
Distributed to:
* via CE Bulletin |
>Page 2 |
||||||||||||
| Contacts: Details of manufacturer and MHRA contacts for technical and clinical aspects. Change of address or removal from address list for CSCI and Healthcare Commission. |
>Page 3 |
||||||||||||
| Appendix: Extract from manufacturer’s instructions for use (in pdf only). |
>Page 4 |
|
Action deadlines for the Safety Alert Broadcast System (SABS)
|
|
|
Deadline (action underway): 07 January 2008
|
Deadline (action complete): 11 February 2008
|

