Print version of this report
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 B Braun Australia Pty Ltd
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