Events

Retiro De Equipo (Recall) de Arterial Cannulae and Customised Tubing Packs including the 3/8” Vent plug 70000.8256

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Getinge 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-00435-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2018-05-09
  • 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-00435-1
  • 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
    An arterial cannula used for open heart surgery is normally equipped with a vent plug, which facilitates the de-airing of the cannula.The vent plug of our 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.Getinge has been made aware that in some instances, the vent plug can break during the separation from the arterial cannula.
  • Acción
    Getinge is advising customers to immediately return affected product to their local Getinge representative. Due to the discontinuation of the Surgical Perfusion Catheters/Cannulae product portfolio, Getinge are not providing replacement.

Device

Arterial Cannulae and Customised Tubing Packs including the 3/8” Vent plug 70000.8256
  • Modelo / Serial
    Arterial Cannulae and Customised Tubing Packs including the 3/8” Vent plug 70000.8256Multiple Material NumbersARTG Number: 206768Getinge Australia - Catheter, intravascular, general-purpose
  • Manufacturer
    Getinge Australia Pty Ltd

Manufacturer

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