Events

Retiro De Equipo (Recall) de Catheter, intravascular, general-purpose

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 Maquet Cardiopulmonary AG.

¿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
    22941
  • Fecha de inicio del evento
    2018-05-07
  • 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: Getinge Australia Pty Ltd (NZ), 12 G Andromeda Crescent, East Tamaki, Auckland 2013
  • Causa
    The vent plug of the arterial cannula consists of sintered polyethylene, therefore the structure of the vent plug is porous and gas-permeable. after the de-airing process is completed the customer has to separate the vent plug from the cannula to connect the extracorporeal circuit., in some cases it has come to the manufacturers attention that the vent plug has broken during the separation from the arterial cannula.
  • Acción
    Product to be returned to supplier

Device

Catheter, intravascular, general-purpose
  • Modelo / Serial
    Model: , Affected: products containing the 3/8" vent plug 70000.8256
  • Manufacturer
    Maquet Cardiopulmonary AG

Manufacturer

Maquet Cardiopulmonary AG
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    NZMMDSA