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: 5 February 2007 at 11:00 |
Ref: MDA/2007/010
|
|
|
Immediate action |
|
Action |
|
|
Update |
|
|
Information request |
| Device: Baxter Continu-Flo solution sets with check valve. Affected product codes: EMC 9603, RMC 9603, RMC 9604, RMC 9619. |
>Page 2 |
||||
| Problem: During secondary infusions, there is the potential for solution from the secondary infusion container to pass through the check valve (one-way valve) on the primary line/set and consequently enter the primary infusion container (‘backflow‘). This backflow will be characterised by a rise of the fluid level in the drip chamber below the primary infusion container. Backflow can result in inadequate treatment by causing an under-infusion of the secondary infusion. |
|
||||
| Action by: All medical and nursing staff. |
|||||
|
Action:
|
|
||||
|
Distributed to:
* via CE Bulletin |
|
||||
| Contacts: Details of manufacturer contacts and MHRA contacts for technical and clinical aspects. Change of address or removal from address list for Healthcare Commission. |
>Page 3 |
|
Action deadlines for the Safety Alert Broadcast System (SABS)
|
|
|
Deadline (action underway): 26 February 2007
|
Deadline (action complete): 19 March 2007
|

