Events

Alerta De Seguridad para Infusion Pump PLUM A +

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 Hospira Costa Rica Ltd || Hospira Inc..

¿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
    A1604-172
  • Número del evento
    2008EBC-0001789
  • Fecha
    2016-04-29
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=144
  • 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 some of the medical-referenced devices were not properly calibrated during the manufacturing process, as a result, the bombasafectadas can produce false proximal occlusion alarms during the initialization of the cassette (therapy configuration) or they could be delayed in the event of an occlusion. proximal during the delivery of therapy, which can lead to potentially serious adverse events occur on the patient.

Device

Infusion Pump PLUM A +
  • Modelo / Serial
    12391-88-05 and 20792-88-69, specific serials.
  • Descripción del producto
    To perform scheduled delivery of fluids, blood products and drugs parenterally, enterally and epidurally.
  • Manufacturer
    Hospira Costa Rica Ltd || Hospira Inc.

Manufacturer

Hospira Costa Rica Ltd || Hospira Inc.
  • Empresa matriz del fabricante (2017)
    Pfizer
  • Source
    NIDFSINVIMA