Events

Alerta De Seguridad para Infusion pump Graseby

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 Smiths Medical Md, 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
    R1710-461
  • Número del evento
    2009EBC-0004058
  • Fecha
    2017-10-02
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=71
  • 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 been able to identify that in some cases the lock and key provided with the referenced equipment does not correspond to the standard key, the affected equipment was manufactured or revised between october 30, 2015 and april 6, 2016, the key provided allows to close and open but can not be shared between the different affected pumps and the others as it should happen, this key is necessary to unlock the safety box and be able to program an infusion, change or restart an infusion that has been interrupted, leading to possible delays in procedures or adverse events. the patients.

Device

Infusion pump Graseby
  • Modelo / Serial
    3300, concerning the accessories of the 3000 GRASEBY series
  • Descripción del producto
    Indicated for infusion in the intravenous, intraarterial, subcutaneous, intraperitoneal, epidural or subarachnoid space.
  • Manufacturer
    Smiths Medical Md, Inc

Manufacturer

Smiths Medical Md, Inc