Events

Rappel de Alaris System Syringe Module

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par CareFusion Australia 316 Pty Ltd.

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-2015-RN-01080-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-11-06
  • 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-2015-RN-01080-1
  • 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
    There has been a previous notification (tga ref.: rc-2015-rn-00767-1) for devices manufactured during a specific time period, however further root cause analysis has shown all manufactured syringe drivers/modules prior to july 2015 are affected. carefusion has received service reports of a channel error on the alaris system syringe module model 8110. a channel error is displayed on the syringe module in association with an audible and visual alarm on the attached pc unit (error code 351.6740); once cleared on the pcu the syringe module remains unresponsive to key presses until the next power cycle, or the module is detached and re-attached. this error could occur during an infusion causing an interruption of infusion.
  • Action
    CareFusion will adjust the syringe drive train assembly on the affected units and replace, if required. This action has been closed-out on 06/09/2016.

Device

Alaris System Syringe Module
  • Modèle / numéro de série
    Alaris System Syringe Module Model Number: 8110Material Number:10930269Serial Numbers: ALL distributed Alaris System Syringe modules in Australia to dateARTG Number: 175353
  • Manufacturer
    CareFusion Australia 316 Pty Ltd

Manufacturer

CareFusion Australia 316 Pty Ltd