Events

Retiro De Equipo (Recall) de 5008 PAED Therapy 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 Fresenius Medical Care Australia 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-2018-RN-00885-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2018-07-05
  • 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-2018-RN-00885-1
  • 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
    The hd-paed option is available for dialysis 5008 systems for patients with a lower body weight. fresenius medical care has undertaken a review of the hazards identified with the use of the hd-paed option and determined that it is no longer possible to uphold the currently defined lower limit of 10 kg of body weight in the intended use for a safe application. as a result, fresenius medical are limiting the intended use to = 17 kg of body weight.To date, no related incidents for patients between 10kg and 40kg have been reported.
  • Acción
    Fresenius Medical Care is advising that the intended use of the HD-PAED option has been revised to = 17 kg of body weight. The Instructions For Use (IFU) of the 5008 Paediatric Haemodialysis Therapy System will be adapted accordingly. Customers are requested to exchange the relevant page in the IFU with the addendum included with the Customer Letter.

Device

5008 PAED Therapy System
  • Modelo / Serial
    5008 PAED Therapy SystemARTG Number: 120309(Fresenius Medical Care Australia Pty Ltd - Haemodialysis Machines - Haemodialysis unit)
  • Manufacturer
    Fresenius Medical Care Australia Pty Ltd

Manufacturer

Fresenius Medical Care Australia Pty Ltd