Events

Alerta De Seguridad para CVI angiographic injection 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 Acist Medical 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
    R1512-592
  • Número del evento
    2013EBC-0010276
  • Fecha
    2015-12-29
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=163
  • 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 air entrances were presented in one of the two collectors of the referenced device; in a preventive manner, it has initiated the withdrawal of the potentially involved lots.

Device

CVI angiographic injection system
  • Modelo / Serial
    BT2000 and CPT2000, specific lots.
  • Descripción del producto
    The ACIST injection system is an angiographic injection system that provides radiopaque contrast media with a variable flow and volume defined by the medical staff. The system has been designed for the controlled perfusion of radiopaque contrast media (not included in this application) in angiographic procedures.
  • Manufacturer
    Acist Medical Systems, Inc.

Manufacturer

Acist Medical Systems, Inc.
  • Empresa matriz del fabricante (2017)
    Bracco Spa
  • Source
    NIDFSINVIMA