Events

Retiro De Equipo (Recall) de Machines for extracorporeal blood treatment -2008, 4008, 5008, Genius, Prometheus, etc

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Fresenius Medical Care AG & Co KGaA.

¿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
    23312
  • Fecha de inicio del evento
    2018-07-09
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Fresenius Medical Care Australia Pty Ltd (NZ), 60 Pavillion Drive, Airport Oaks, AUCKLAND
  • Causa
    The manufacturer has undertaken a review of the hazards identified with the use of the 5008 paed therapy system 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, the manufacturer are limiting the intended use to >17 kg of body weight.
  • Acción
    Instructions for use to be updated

Device

Machines for extracorporeal blood treatment -2008, 4008, 5008, Genius, Prometheus, etc

Manufacturer

Fresenius Medical Care AG & Co KGaA