Events

Retiro De Equipo (Recall) de MAQUET QUADROX-i Oxygenators (excluding HLS) and Blood Outlet Connectors-QUADROX-i(D) adult, small adult, paediatric and neonatal with Softline and Bioline Coating-PLS-i gas exchanger in PLS sets -PLS gas exchanger in HIT -PLS sets-Quadrox-iR with Softline coating

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Maquet 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-2013-RN-00239-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-03-15
  • 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-2013-RN-00239-1
  • 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
    Outlet connector detachment may result in rapid blood loss which could cause serious injury or death. this issue was originally reported under recall rc-2012-rn-00551-3. although the correction implemented for the previous recall reduced the incidence rate of detachment from 0.01% to 0.001%, a patient death potentially attributed to detachment of the outlet connector was reported recently.
  • Acción
    Customers are requested to continue to confirm the integrity of the oxygenator prior to use. The devices should only be used if the connector is secure. Maquet is implementing a stainless steel retainer clamp as a short term correction. A permanent mechanical fitting is currently under development and is expected to be implemented in late 2013. This action has been closed-out on 14/04/2016.

Device

MAQUET QUADROX-i Oxygenators (excluding HLS) and Blood Outlet Connectors-QUADROX-i(D) adult, smal...
  • Modelo / Serial
    MAQUET QUADROX-i Oxygenators (excluding HLS) and Blood Outlet Connectors-QUADROX-i(D) adult, small adult, paediatric and neonatal with Softline and Bioline Coating-PLS-i gas exchanger in PLS sets -PLS gas exchanger in HIT -PLS sets-Quadrox-iR with Softline coating
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

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