Events

Retiro De Equipo (Recall) de AQURE data management system

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Radiometer Pacific 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-2016-RN-00015-2
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-01-06
  • 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-2016-RN-00015-2
  • 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 potential clinical issue with aqure if the data management system is being used to interpret patient results for the management of treatment. the issue occurs when a sample type is not provided from a device. an example is where results from a sample type of “urine” (not displayed) are compared to results from a sample type “arterial”. in this case a clinician may incorrectly take action based on an assumption that all results are from a sample type “arterial”. this may lead to wrongful diagnosis and wrongful treatment of the patient which can result in immediate as well as long term critical health consequences for the patient.
  • Acción
    The sponsor will contact the affected customers to arrange for the installation of a database script which will mitigate the risk as a temporary measure. A final solution involving a software upgrade will be provided to the customers when it becomes available. In the meantime, the AQURE system can continue to be used but users are advised to interpret blank fields for sample type as "not specified".

Device

AQURE data management system

Manufacturer

Radiometer Pacific Pty Ltd