Events

Rappel de MAQUET Heart Lung Machine - HL30 (Heart-lung bypass system)

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-00104-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-02-05
  • 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-00104-1
  • 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
    Maquet has identified two potential issues with the hl30 device which will be addressed in a software upgrade. first, in rare instances, as a result of an accidental impact or bump to the pump head cover, the unit may stop. this stoppage is intended to occur by design whenever the pump head cover is opened during operation. however if it occurs due to a rapid impact, the unit may stop without an informational message explaining the reason for the stoppage. secondly, in a limited number of cases, the unit slave pump did not engage after cardioplegia pause.
  • Action
    Maquet is advising that if the unit stops, it can be reset by turning the potentiometer to zero. If the software anomaly with the cardioplegia module was to occur, the patient can be cross-clamped until the unit restarts, or transferred to another device. A Maquet Australia representative will be in contact with relevant staff at affected facilities to schedule the implementation of the corrective action.

Device

MAQUET Heart Lung Machine - HL30 (Heart-lung bypass system)
  • Modèle / numéro de série
    MAQUET Heart Lung Machine - HL30 (Heart-lung bypass system)All devices affectedARTG Number: 179104
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

Maquet Australia Pty Ltd
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    DHTGA