Events

Recall of Injectomat Agilia Range (Std, MC & TIVA), Volumat Agilia Range (Std & MC)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Fresenius Kabi Australia Pty Limited.

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-2014-RN-00493-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-07-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00493-1
  • 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
    Frensenius kabi initiated a software upgrade due to three incident reports concerning three different issues:injectomat and volumat pumps:1. the pdms from picis implemented an unexpected high number of connection/disconection requests resulting in a "watchdog" error message.2. if the user configured the vigilant drug lib software with a drug with fixed dilutions, the selection on the pump of this drug as a first step then followed by the selection of 'drug x in ml/hr' as a second step could result in the display of a technical error. concerning injectomat pumps: 3. in a high vibration environment, for example close to the warming device, the syringe installation check sensor signal can be unstablepotentially triggering a technical error (n-deg 23).This action was undertaken prior to notifying the tga.
  • Action
    Fresenius Kabi has updated the software of all affected Injectomat and Volumat devices.

Device

Injectomat Agilia Range (Std, MC & TIVA), Volumat Agilia Range (Std & MC)

Manufacturer

Fresenius Kabi Australia Pty Limited