Events

Alerta De Seguridad para Advanced Perfusion 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 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
    I1404-158
  • Número del evento
    2010EBC-0005399
  • Fecha
    2014-04-16
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=205
  • 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 it has detected that the manual does not provide a complete and clear description of the response of the centrifugation system of the pump, as well as information about the message "999" and "service of the pump", since these could cause that errors of interpretation by part of the user and potentially adverse events on the patient.

Device

Advanced Perfusion System
  • Modelo / Serial
    SYSTEM 1
  • Descripción del producto
    Used in the extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures only when used by an expert perpermist in the operation of TERUMOCARDIOVASCULAR SYSTEMS or similar equipment. Centrifugal pump is used in bypass cardiopulmonary procedures only. The pressure monitoring kit is used with physiological pressure transducers that measure the pressure of fluids in an infusion circuit.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

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