Events

Recall of B. Braun Infusomat Space Infusion System (infusion pump)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by B Braun Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2012-RN-00927-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-09-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00927-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    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.
  • Action
    The sponsor will be providing a software and hardware update to mitigate the issue.

Device

B. Braun Infusomat Space Infusion System (infusion pump)
  • Model / Serial
    B. Braun Infusomat Space Infusion System (infusion pump)Model Numbers: 8713050, 8713050-99, 8713050, 8713060U, 8713060U-99 with software version G03, G02 or olderAffected pumps were distributed from 6 November 2008 to 29 December 2011
  • Manufacturer
    B Braun Australia Pty Ltd

Manufacturer

B Braun Australia Pty Ltd