Events

Alerta De Seguridad para pump for enteral nutrition

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 Kabi AG.

¿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
    I1407-286
  • Número del evento
    2014EBC-0011079
  • Fecha
    2014-07-14
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=200
  • 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 risk for damage to the charger, which can be separated and leave the electronic components exposed, causing possible electric shocks, which can lead to adverse events on the patient or user.

Device

pump for enteral nutrition
  • Modelo / Serial
    AMIKA references Z044110, serials before 00019160
  • Descripción del producto
    This device is a peristaltic pump specialized in enteral nutrition. It is used to administer a volume of nutrition to a programmed flow to the patient (human solos). It is designed to administer fluids through nasogastric or percutaneous gastrostomy feeding tubes, and to administer any type of fluid enteral malnutrition; for example: drinking water (with or without gas), tea, soft drinks, fresh water and the full range of products prepared from FRESENIUS KABI. This pump can be used on one patient at a time and on multiple patients during its lifetime.
  • Manufacturer
    Fresenius Kabi AG

Manufacturer

Fresenius Kabi AG