Events

Alerta De Seguridad para Injectomat infusion pump

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 Fresenius Vial S.A.S.

¿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
    I1404-157
  • Número del evento
    2013EBC-0009714
  • 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 reports that it has detected a potential failure in some software versions making the necessary adjustments to it to solve them, as these could cause potentially adverse events to occur on the patient.

Device

Injectomat infusion pump
  • Modelo / Serial
    MC AGILIA - Z018010, Z018110, Z018210, Z019010 and Z019110
  • Descripción del producto
    INJECTOMAT MC AGILIA is a syringe pump with dosing functions. It is handled intuitively and is very easy to learn, like all AGILIA products. The plunger protector, infusion and pressure control, and the use of clear messages and symbols minimize risks during infusion. Thanks to the different security systems and the VIGILANT DRUG'LIB mode, INJECTOMATMC AGILIA is especially indicated in special services and uci rooms.
  • Manufacturer
    Fresenius Vial S.A.S

Manufacturer

Fresenius Vial S.A.S