Events

Alerta De Seguridad para System for Fluid Heating RANGER 245

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 3M Health Care.

¿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
    I1510-485
  • Número del evento
    2010DM-0005465
  • Fecha
    2015-10-29
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=169
  • 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 states that the operation of the medical device can be affected by the close use of finger-way radios, causing the activation of an audible and visual alarm of high or low temperature or the unstable operation thereof, leading to the occurrence of adverse events or delays in the patient care.

Device

System for Fluid Heating RANGER 245
  • Modelo / Serial
    RANGER 245
  • Descripción del producto
    The RANGER heating system is designed to heat blood, blood products and liquids. The heating system for blood and fluids RANGER is a device composed of a heating unit and a disposable equipment for the administration of blood and fluids intravenously (IV), the heating system RANGER is designed to heat blood, blood products and liquids and achieves a speed of MVA flow rate at 500ml per minute. Two disposable equipment for blood and fluids can be obtained: one for normal flow applications and one for high flow applications. These disposable equipment, designed for use in reusable dewaxing units, are sterilized, do not contain latex and are for single use only.
  • Manufacturer
    3M Health Care

Manufacturer

3M Health Care
  • Empresa matriz del fabricante (2017)
    3m Company
  • Source
    NIDFSINVIMA