Events

Safety Alert for System for High Permeability Hemodialysis PRISMAFLEX

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Gambro Lundia AB.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    I1502-58
  • Event Number
    2010EBC-0006651
  • Date
    2015-02-09
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=186
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    The manufacturer states that after updating the software to version 7.11 of the referenced equipment, auditory alarms can be difficult to recognize due to changes in their presentation (volume and tone), possibly resulting in medical personnel not being familiar with the conditions of the alarm, leading to possible adverse events on the patients.

Device

System for High Permeability Hemodialysis PRISMAFLEX
  • Model / Serial
  • Product Description
    The PRISMAFLEX control unit is indicated for: continuous renal replacement therapy (CRRT) for patients with acute renal failure and / or fluid load. Therapeutic exchange therapy deplasma (TPE) for contrastor patients in whom withdrawal of plasma components is indicated
  • Manufacturer
    Gambro Lundia AB

Manufacturer

Gambro Lundia AB