Events

Rappel de Alaris 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-2017-RN-00138-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-01-27
  • 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-2017-RN-00138-1
  • 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
    Becton dickinson (bd) has identified a software anomaly with the alaris syringe module, model 8110; software version 9.15. this anomaly may cause a small percentage of syringe infusions to unexpectedly stop when an infusion is transitioning from one state to another. infusion transitions that may be impacted by the failure are: - a complete bolus transitioning to a continuous infusion - a basic, continuous or intermittent infusion transitioning to near end of infusion (neoi) state - a basic, continuous or intermittent infusion transitioning to a keep the vein open (kvo) state the error code will cause an audible and visual alarm on the alaris pc unit and scroll a channel error message on the alaris syringe module. becton dickinson is not aware of any report of injury attributed to this defect.
  • Action
    BD will arrange for a product correction (i.e. software upgrade) to mitigate the issues. In the interim, users are advised that if error code 351.6610 occurs, the user can clear the channel error by pressing “CONFIRM”. After the channel error is cleared on the PC unit, the user can detach and re-attach the module to restart the infusion, or power off the PC unit and then power back on to restart a new infusion. The user should replace the affected Syringe module as soon as possible and isolate the Alaris Syringe module that exhibits the channel error code.

Device

Alaris Syringe Module

Manufacturer

CareFusion Australia 316 Pty Ltd