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MDA/2007/010 - Baxter Continu-Flo solution sets with check valve

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Document details:

Type: Medical Device Alert
Series No: MDA/2007/010
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 4
Price: Free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Issued: 5 February 2007 at 11:00
Ref: MDA/2007/010


 
Immediate action
Tick mark
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:

  • Follow proper priming techniques as stated in the manufacturer’s instructions for use.
  • Ensure hanger included with sets is utilised to ensure that the primary container is below the secondary as per the manufacturer’s instructions for use.
  • Closely monitor the fill volume level of the primary drip chamber for a rise in fluid level.

 

Distributed to:

NHS trusts in England - Chief Executives*
Healthcare Commission (CHAI) - Headquarters

* 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


Page last modified: 07 February 2008