Events

Rappel de AQUARIUS Regional Citrate Anticoagulation (RCA) Hemofiltration Device

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par AA-Med 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-00118-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-02-17
  • 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-00118-1
  • 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
    Edwards lifesciences (previous legal manufacturer of aquarius devices in the market) initiated a fsca to address the issue related to the potential risk of fluid overload or fluid loss caused by the repetitive clearing of the balance alarm without solving the balance alarm cause. field safety notices were sent to customers warning users about the potential danger for repetitive clearing of the balance alarm without solving the balance alarm cause.Nikkiso europe (manufacturer of aquarius devices) has now completed a software solution to prevent the repeated overriding of the balance alarm by implementing total fluid loss (tfl) management in software 6.02. this product improvement is accompanied by a revised instructions for use (ifu).
  • Action
    Nikkiso Account Manager will contact the customer shortly to schedule the onsite modification, calibration and training based on availability of the hospital staff as well as devices.

Device

AQUARIUS Regional Citrate Anticoagulation (RCA) Hemofiltration Device
  • Modèle / numéro de série
    AQUARIUS Regional Citrate Anticoagulation (RCA) Hemofiltration DeviceProduct Codes: GEF09500, All Citrate Platform 6 Devices ARTG Number:189947
  • Manufacturer
    AA-Med Pty Ltd

Manufacturer

AA-Med Pty Ltd
  • Source
    DHTGA