Events

Alerta De Seguridad para Set for preparation and administration of chemotherapy

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 CAIR LGL.

¿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
    I1403-109
  • Número del evento
    2012DM-0008925
  • Fecha
    2014-03-12
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=207
  • 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 in the mentioned devices, they may present leaks at the level of the "y", leading to potentially adverse events occurring on the patient.

Device

Set for preparation and administration of chemotherapy
  • Modelo / Serial
  • Descripción del producto
    The CHEMO-DRIVE chemotherapy preparation and administration set is a device whose indication for use is the preparation and administration of anti-blast drugs, which are administered to the patient by intravenous route. It is a completely closed, aseptic system that intrinsically makes the mixture of the diluent with the drugs in amounts established in the formulation and afterwards iv administration to the patient with total biosecurity. Because it is a closed system, the medical personnel never come into contact with the dangerous substances of the medica.Se is used for the preparation and administration of complete chemotherapies in a hospital or home environment with total security. Medications to be filled and administered have their sanitary registration.
  • Manufacturer
    CAIR LGL

Manufacturer

CAIR LGL
  • Empresa matriz del fabricante (2017)
    Cair Lgl
  • Source
    NIDFSINVIMA