Events

Rappel de Synthesis, Avant & Primo2x Families Adult Oxygenator Mounting Brackets (used with Sorin 3T Heater-Cooler devices)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par LivaNova 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-2016-RN-00886-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-07-13
  • 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-2016-RN-00886-1
  • 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
    Livanova (sorin) have found that certain oxygenator mounting brackets that include tubing that connects the heater-cooler 3t water circuit to the oxygenator could be a source of re-contamination (with non-tuberculous mycobacteria) of a clean heater-cooler 3t’s water circuit. this tubing is not subjected to disinfection as per the ifu for the heater-cooler. if the heater-cooler 3t user failed to clean and disinfect the heater-cooler 3t resulting in contamination of the heater-cooler 3t and at some point later used oxygenator mounting bracket, the water from the contaminated heater-cooler 3t could cross-contaminate the oxygenator mounting bracket’s internal tubing in which biofilm could develop. if a non-contaminated heater-cooler 3t was later connected to an oxygenator mounting bracket that had been previously cross contaminated, the oxygenator mounting bracket could contaminate the clean heater-cooler 3t.
  • Action
    LivaNova will replace the affected bracket and is providing advice to users on how to dispose of the affected Oxygenator bracket. The existing brackets can be used until a replacement unit can be provided.

Device

Synthesis, Avant & Primo2x Families Adult Oxygenator Mounting Brackets (used with Sorin 3T Heater...
  • Modèle / numéro de série
    Synthesis, Avant & Primo2x Families Adult Oxygenator Mounting Brackets (used with Sorin 3T Heater-Cooler devices)D632 Adult Open System Bracket Catalogue Number: 05046Adult Oxy module Avant Bracket Catalogue Number: 050128Synthesis “C” BracketCatalogue Number: 050350Synergy Bracket Catalogue Number: 050131D626 Avant Holder Catalogue Number: 05040D630 Avant Holder Catalogue Number: 05041Synthesis Oxygenator Holder Catalogue Number: 050127ARTG # 194514
  • Manufacturer
    LivaNova Australia Pty Ltd

Manufacturer

LivaNova Australia Pty Ltd