Events

Alerta De Seguridad para Sarns Centrifugal System, Control Module

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Terumo Cardiovascular Systems Corporation.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2012-11-02
  • Fecha de publicación del evento
    2012-11-02
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121102.html
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    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