Events

Alerta De Seguridad para Infusion pump CAESAREA

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 Caesarea Medical Electronics Ltd..

¿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
    I1402-68
  • Número del evento
    INVIMA 2009EBC-0005004
  • Fecha
    2014-02-14
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=209
  • 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
    He mentions that lithium batteries have deformation to increase its dimensions by chemical reactions inside it, which can separate the shell of the pump to prevent the malfunctioning of the biomedical equipment, leading to the occurrence of potentially adverse events on the patient.

Device

Infusion pump CAESAREA
  • Modelo / Serial
    BODYGUARD 575
  • Descripción del producto
    This equipment is designed for the infusion of medications or fluids that require continuous or intermittent delivery with precise and controlled infusion rates through clinically acceptable routes, including intravenous, subcutaneous, percutaneous, intrarterial, epidural, enteral, near the nerves and within an intraoperative site
  • Manufacturer
    Caesarea Medical Electronics Ltd.

Manufacturer

Caesarea Medical Electronics Ltd.