Type of Product |
Medical Device |
TGA Recall Reference |
RC-2012-RN-00927-1 |
Product Name/Description |
B. Braun Infusomat Space Infusion System (infusion pump)
Model Numbers: 8713050, 8713050-99, 8713050, 8713060U, 8713060U-99 with software version G03, G02 or older
Affected pumps were distributed from 6 November 2008 to 29 December 2011 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class II |
Recall Action Commencement Date |
13/09/2012 |
Responsible Entity |
|
Reason/Issue |
This is an expansion of a previous recall, initiated by B. Braun in January 2012 due to the potential for breakage of the anti free flow clip located inside the infusion pump door. Breakage may occur when the IV set anti free flow clip catch is inserted improperly into the pump and the pump door is forced closed. Misloading of the anti free flow clip catch may create the potential for free flow of medication. Free flow, specially of narrow therapeutic range drugs, can cause life-threatening effects and injuries.
This recall action was not notified to the TGA before it was initiated by B. Braun. |
Recall Action |
Recall for Product Correction |
Recall Action Instructions |
The sponsor will be providing a software and hardware update to mitigate the issue. |
Contact Information |
02 9629 0200 - B. Braun |