Events

Alerte De Sécurité sur Sarns Centrifugal System, Control Module

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 Corporation.

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_20121102.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 centrifugal system, control module medical device manufacturer, terumo cardiovascular systems corporation (terumo cvs), has initiated a field safety corrective action concerning the control module for sarns centrifugal system, 100/115v. terumo cvs has received multiple reports since 2004 of malfunctions related to components of the sarns centrifugal system, including the centrifugal system for the sarns perfusion system 9000. the reports can be broadly categorized as loss of forward flow, motor noise/vibration, missing/inaccurate flow data, erratic operation, unexpected error messages/alarms, module reset, and smoke seen or smelled. if the centrifugal system is used as the arterial pump, a malfunction could result in loss of arterial flow and a backflow condition. furthermore, if the centrifugal system is used for kinetic-assisted venous drainage, a malfunction could result in inadequate venous drainage. there have been no reports of patient injury as a result of this issue. terumo cvs is notifying users of the reported malfunctions reminding them to review the existing instruction in the operator’s manual, and will provide users an addendum with additional information on reducing patient risk in the event of a malfunction which include a warning to have emergency equipment (manual drive or another pump) and an emergency protocol available, and a recommendation to use a one-way valve. according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 2 november 2012.

Device

Sarns Centrifugal System, Control Module

Manufacturer

Terumo Cardiovascular Systems Corporation