Events

Rappel de CP5 control panels and HLM bubble sensors and EP packs manufactured prior to 10 February, 2017

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-01408-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-11-13
  • 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-2017-RN-01408-1
  • 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
    During internal testing, livanova identified that there is a possibility that the automatic line closure by the erc clamp after detection of an air bubble could take longer than is intended by design in the cp5 system. this could lead to the remote possibility of an air bubble reaching a patient before the clamp closes if the blood flow rate is high and the distance between the bubble sensor and the patient is set at the minimum required by the ifu (1 metre). to date, livanova has not received any reports that an air bubble has passed the erc clamp, nor have there been any reports of patient injury associated with this issue.
  • Action
    LivaNova is advising users to ensure an arterial filter is used to reduce the probability of air ingress to the patient's bloodstream. LivaNova will be installing a firmware upgrade as a permanent correction.

Device

CP5 control panels and HLM bubble sensors and EP packs manufactured prior to 10 February, 2017
  • Modèle / numéro de série
    CP5 control panels and HLM bubble sensors and EP packs manufactured prior to 10 February, 2017ARTG Number: 94208 (LivaNova Australia Pty LtdCirculatory assist unit, pump, centrifugal)
  • Classification du dispositif
    Cardiovascular Devices
  • Manufacturer
    LivaNova Australia Pty Ltd

Manufacturer

LivaNova Australia Pty Ltd