Events

Alerta De Seguridad para Modular Perfusion System SARNS 8000

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 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
  • ID del evento
    I1703-93
  • Número del evento
    2012EBC-0000781-R1
  • Fecha
    2017-03-13
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=97
  • 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
  • Causa
    The manufacturer informs that the referenced medical devices can show on their label an expiration date in a format that is unrecognizable to the user, if a user can not correctly know the expiration date and uses a product that has been made, the adherence of the sensor may not be correct and carry an inadequate interface, which could lead to delays in patient care.

Device

Modular Perfusion System SARNS 8000
  • Modelo / Serial
  • Descripción del producto
    Heart / lung machine with 4 to 5 modules where modular blood pumps can be accommodated. It is a complete machine for cardiothoracic surgery, this basic system includes a safety monitor for the detection of air bubbles, the monitor receives energy from the stop line and transmits signals to the base.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation
  • Empresa matriz del fabricante (2017)
    Terumo Corp.
  • Source
    NIDFSINVIMA