Events

Alerta De Seguridad para Temporary Total Artificial Heart System

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por Syncardia Systems. Inc..

¿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
  • ID del evento
    I1801-74
  • Número del evento
    2016EBC-0014444
  • Fecha
    2018-01-31
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=57
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notas adicionales en la data

Device

Temporary Total Artificial Heart System
  • Modelo / Serial
    Freedom console reference 595000-001
  • Descripción del producto
    The TAH-T temporary total artificial heart system is indicated as a bridge to cardiac transplantation in patients who are eligible due to the risk of imminent death due to biventricular failure. The total-temporal artificial heart is indicated in eligible transplant patients at risk of imminent death due to biventricular terminal failure. Persistent ventricular tachycardia, refractory cardiogenic shock, rejection of the biological heart transplant, cardiac amyloidosis, congenital heart conditions. The TAH-T system is designed for use in hospital during and after the surgical implantation of the TAH-T. The Freedom driver system used with 50cc and 70cc TAH-T is designed for intrahospital and extrahospital use. The TAH-T system with the Freedom driver system is indicated for use as a translational bridge in patients who are candidates for heart transplantation in whom the TAH-T has been implanted and are clinically stable.
  • Manufacturer
    Syncardia Systems. Inc.

Manufacturer

Syncardia Systems. Inc.