Events

Rappel 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

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Maquet Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2013-RN-00239-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-03-15
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00239-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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...
  • Modèle / numéro de série
    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
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    DHTGA