Events

Rappel de ClearSight Heart Reference Sensor

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Edwards Lifesciences 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-01537-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-12-22
  • 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-01537-1
  • 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
    Edwards lifesciences has been made aware of reports of “out of range” error messages for the edwards clearsight heart reference sensor. an analysis of evhrs out of range complaints led to the determination that the product is not meeting the current labelled shelf life (expiry date) of 730 days (2 years) from the date of manufacture. as a result, edwards lifesciences are amending the expiration date to six months from the date of manufacture. there have been no reported patient injuries as a result of this issue.
  • Action
    Edwards Lifesciences are advising customers that they will be in contact with affected users to arrange for replacement of the device. In the interim, if users do not encounter the "HRS Out of Range" message on the EV1000 clinical platform, the HRS is functioning properly and patient monitoring is not adversely impacted.

Device

ClearSight Heart Reference Sensor
  • Modèle / numéro de série
    ClearSight Heart Reference SensorModel Number: EVHRSAll serial numbers manufactured after December 31, 2015ARTG Number: 219809
  • Manufacturer
    Edwards Lifesciences Pty Ltd

Manufacturer

Edwards Lifesciences Pty Ltd