Events

Rappel de Sorin Group perfusion system – Heater Cooler 3T 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-2017-RN-01368-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-10-27
  • 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-01368-1
  • 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 is issuing a recall for product correction to inform users about the retrofit of their heater cooler 3t devices to implement a vacuum and sealing upgrade. this modification to the internal design of the 3t heater-cooler device will collect any aerosols that are potentially contaminated with nontuberculous mycobacterium (ntm), preventing those aerosols from entering into the sterile operating field.Livanova is also notifying that the 3t device will be suspended from the australian register of therapeutic goods (artg) beginning 8 november 2017 for a period of up to 6 months. the reason for this suspension is that the minncare disinfectant is not listed on the artg with the same classification as the 3t device. however, during this period, livanova will be able to supply loan units on an as-needed, no-charge basis to ensure continuity of clinical practice.
  • Action
    LivaNova has completed the development of a TGA approved correction that mitigates against this potential contamination by preventing dispersion of aerosols produced by the heater-cooler in the operating room. This correction will be implemented by an onsite enhancement of units currently in use by LivaNova service personnel or a local agent. Although this issue is less likely when the 3T device’s water system is maintained according to the current IFU, this product correction will mitigate against the reasonably foreseeable hazard of patient infection which may be potentiated by poor maintenance practices.

Device

Sorin Group perfusion system – Heater Cooler 3T devices

Manufacturer

LivaNova Australia Pty Ltd