Events

Rappel de PLEGIOX Cardioplegia Heat ExchangerAll Standalone PLEGIOX Cardioplegia Heat Exchangers and those included in tubing sets.

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Getinge 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-2017-RN-00978-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-08-08
  • 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-2017-RN-00978-1
  • 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
    The plegiox heat exchanger is used to set and maintain the temperature (for given flow rates and within the given temperature range) of blood cardioplegia and / or crystalloid cardioplegia solutions during extracorporeal circulation. the plegiox heat exchanger consists of two liquid circulations strictly separated from each other by a separating barrier to separate both liquids from each other and to effect thermal transfer at the same time; the design of the plegiox uses hollow fibres made of polyurethane. hollow fibres serve as barrier separating the circulating liquids while effecting thermal transfer. maquet cardiopulmonary gmbh (mcp) internal investigations have revealed that the specification of the performance factor (pf) at flow rates of 1 litre per minute is not always maintained as defined in instruction for use (ifu). deviations up to minus 20% were identified during in-house testing. zero adverse events have been reported in relation to this insufficiency.
  • Action
    Getinge seeks to notify users that: When using the PLEGIOX, the flow rate should be no higher than 500 ml/min to ensure reasonable performance.

Device

PLEGIOX Cardioplegia Heat ExchangerAll Standalone PLEGIOX Cardioplegia Heat Exchangers and those ...
  • Modèle / numéro de série
    PLEGIOX Cardioplegia Heat ExchangerAll Standalone PLEGIOX Cardioplegia Heat Exchangers and those included in tubing sets.Reference Numbers: 703006246, 703006285, 703006317ARTG Number: 158781
  • Manufacturer
    Getinge Australia Pty Ltd

Manufacturer

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