Events

Rappel de Alaris System Point of Care Unit (PC unit)

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-2016-RN-01565-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-12-12
  • 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-2016-RN-01565-1
  • 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
    The manufacturer has received reports of the alaris system pc units operating on battery power where the low battery alarm and/or the very low battery alarm, which should activate when 30 minutes and 5 minutes of estimated battery runtime remains, are not being triggered before the pc unit displays a battery discharge alarm and all infusion channels are stopped. this issue does not occur if device is plugged into ac outlet. if the operator is unaware of a low battery power state because alarms have not been generated, there will be an interruption of infusion due to lack of power. the infusion will stop until the user can provide alternate means of power/replacement device. root causes: batteries not adequately maintained, use of non-authorised batteries, batteries near the end of usual life and battery conditioning test performed in maintenance mode.In past 12 years there have been 58 reports of this issue globally. the manufacturer is not aware of any report of injury in australia.
  • Action
    CareFusion is advising customers of the following. Whenever possible, keep the PC unit plugged into AC power. If the PC unit is disconnected from AC power and the battery is used, ensure that the PC unit is returned to the AC power as soon as possible. After the device has been used on battery power, ensure that the battery is fully recharged prior to using the device on battery power again. Special care should be taken for critical infusions to ensure that AC power is used whenever possible and that batteries are fully charged before the battery is used. (e.g. when transporting patients). CareFusion is also providing customers with updates to the user manual and battery conditioning and battery maintenance processes in the form of a User Manual Addendum for Battery Care and Maintenance and also Service Bulletin 592.

Device

Alaris System Point of Care Unit (PC unit)
  • Modèle / numéro de série
    Alaris System Point of Care Unit (PC unit)Model Numbers: 8000, 8015 All software versions and Serial Numbers affectedARTG Number: 146664
  • Manufacturer
    CareFusion Australia 316 Pty Ltd

Manufacturer

CareFusion Australia 316 Pty Ltd