Events

Rappel de Alaris System PC Unit model 8015

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-00289-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-03-31
  • 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-00289-1
  • 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
    Carefusion usa (the manufacturer) has identified an issue with the pc unit model 8015 following receipt of reports from customers experiencing a system error. a system error (code 110.6021) is displayed with concurrent audio and visual alarm, however it cannot be cleared by restarting or rebooting the pc unit. the error code may occur upon power on during the “power-on self test” due to a keypad issue. the power-on self test is designed to occur during power on, in order to detect issues prior to initiation of an infusion. the system cannot be cleared by restarting or rebooting the pc unit.
  • Action
    CareFusion will replace the affected front keypad assembly on the Alaris PC unit. In the interim end users have been provided with work around instructions to minimise risk to patients. This action has been closed-out on 12/08/2016.

Device

Alaris System PC Unit model 8015
  • Modèle / numéro de série
    Alaris System PC Unit model 8015Material Codes: 8015LSBIXEN9121; 8015LSAIXE9121; 8015LSCIXE91240; 12279909Manufactured between September 1, 2012 and October 22, 2013 having a 5.7” screenARTG Number: 146666
  • Manufacturer
    CareFusion Australia 316 Pty Ltd

Manufacturer

CareFusion Australia 316 Pty Ltd