Events

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

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Fresenius Kabi Australia Pty Limited.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2014-RN-00493-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-07-18
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00493-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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