Events

Alerte De Sécurité sur Sarns Modular Perfusion System 8000

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 Cardiovascular Systems.

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
    2012-11-02
  • Date de publication de l'événement
    2012-11-02
  • 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_20121102a.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
    Medical device safety alert: terumo sarns modular perfusion system 8000 medical device manufacturer, terumo cardiovascular systems corporation (terumo cvs) has initiated a field safety corrective action concerning sarns modular perfusion system 8000. terumo cvs has received multiple reports since 2007 of various malfunctions of the power distribution and battery back-up systems for the sarns modular perfusion system 8000. very few of the reports occurred during cardiopulmonary bypass; the majority of the malfunctions occurred during set-up or were reported during routine preventative maintenance. the malfunctions can be broadly categorized as loss of wall (ac) power, battery back-up malfunction and battery status indicator malfunction. terumo cvs’ initial investigation found that the operator's manual for the sarns system 8000 does not provide sufficient instruction on how to respond to a flashing red indicator light and how to ensure the function of the battery back-up prior to each case. there were no known reports of patient injury as a result of these issues. the manufacturer is informing sarns system 8000 users of the risks associated with these malfunctions and providing an addendum to inform the user with additional instructions. according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the product, please contact your supplier for necessary actions. posted on 2 november 2012.

Device

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

Manufacturer

Terumo Cardiovascular Systems