Events

Alerta De Seguridad para Solution for Dialysis in Renal Replacement Therapy

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 Gambro Renal Products, 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
    R1607-274
  • Número del evento
    2010DM-0005701
  • Fecha
    2016-07-07
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=133
  • 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 has detected the presence of leaks near the upper part of the bags of the device, which may cause microbial contamination of the dialysate, leading to potentially adverse events occurring in patients.

Device

Solution for Dialysis in Renal Replacement Therapy
  • Modelo / Serial
    105351 - PRISMASATE BGK 2/0, lots 1000123133 and 1000128162 distributed between 10/27/2015 and 01/30/2016.
  • Descripción del producto
    Adjuvant solution of hydro-electrolyte balance and PH in patients under renal substitution contains. The PRISMASATE solutions are sterile, to be used in patients under continuous renal replacement in patients with acute renal failure, and in other cases, when fluid or solute removal is required, as in cases of acute poisoning due to medications or drugs that can be dislodged, PRISMASATE does not enter contact with the patient's bloodstream. FIRMASATE solutions are sterile dialysis solutions to be used in continuous renal replacement therapy procedures during the treatment of renal insufficiency and in other indications where the removal of liquids or solutes is required, as in poisoning, which are dialysable.
  • Manufacturer
    Gambro Renal Products, Inc.

Manufacturer

Gambro Renal Products, Inc.