Events

Alerte De Sécurité sur Sarns™ Modular Perfusion System 8000: Cardioplegia Monitor

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Terumo.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2011-09-07
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20110907.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Field safety notice: sarns™ modular perfusion system 8000: cardioplegia monitor terumo has issued an urgent medical device correction on sarns™ modular perfusion system 8000: cardioplegia monitor, a device that displays a various parameters including cardioplegia volume tracking. according to the manufacturer, only certain serial numbers are affected by this safety alert. the manufacturer has received 12 reports that captioned device fails to track the cardioplegia delivery volume as needed due to the loss of communication between the monitor and the cardioplegia pump. the manufacturer revealed that the immediate and long term effects of this failure are minimal and there has been no report of patient injury as result of this issue. to correct the issue, terumo will replace the software on all monitors in the affected devices. affected customer will be contacted and the correction action will be completed within 12 months. >according to the local supplier, hong kong does not bare devices with the affected serial numbers. if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

Sarns™ Modular Perfusion System 8000: Cardioplegia Monitor
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Sarns™ Modular Perfusion System 8000
  • Manufacturer
    Terumo

Manufacturer

Terumo