Events

Retiro De Equipo (Recall) de MOSAIQ version 2.5 and above - Medical Oncology only

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Elekta Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2015-RN-01216-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-12-10
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01216-1
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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.
  • Acción
    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
  • Modelo / Serial
    MOSAIQ version 2.5 and above - Medical Oncology onlyARTG Number: 225164
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

Elekta Pty Ltd
  • Empresa matriz del fabricante (2017)
    Elekta AB
  • Source
    DHTGA