Events

Rappel de MOSAIQ version 2.5 and above - Medical Oncology only

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Elekta 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-01216-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-12-10
  • 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-01216-1
  • 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 is a possibility of incorrect drug dosage calculation due to the following software/data item issues:when there is no valid (unexpired) patient weight entered on the same date or prior to a serum creatinine value being populated, a stale creatinine clearance (crcl) value is being used in area under curve (auc) dose calculations. as a separate issue, if there is a valid age limit added to an elekta metric data item (e.G. weight (kg)) and the same valid age limit has not been added to the elekta imperial data item which corresponds (e.G. weight (lb)), the calculated result which has no valid age will still be considered valid and could be used in drug dose calculations.There is a remote probability that critical harm could occur. no patient injuries have been reported so far.
  • Action
    The sponsor is advising users to implement the following workaround prior to the installation of a software update: always enter a current weight for the patient who is receiving Carboplatin on the same day or prior to the serum creatinine value being populated; Add the valid age in all Elekta data items.

Device

MOSAIQ version 2.5 and above - Medical Oncology only
  • Modèle / numéro de série
    MOSAIQ version 2.5 and above - Medical Oncology onlyARTG Number: 225164
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

Elekta Pty Ltd
  • Société-mère du fabricant (2017)
    Elekta AB
  • Source
    DHTGA