Events

Safety Alert for DIALOG Hemodialysis Equipment

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by B. Braun Avitum Ag.

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
    R1605-203
  • Event Number
    2008EBC-0001989
  • Date
    2016-05-11
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=141
  • 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 has detected the presence of cracks in the conductivity sensors, which could allow elaire to enter the solution (dialysis fluid or dialysate) used to help filter waste and other fluids into the blood, the air into the liquid dialysis can lead to inappropriate blood filtration, leading to adverse events on patients.

Device

DIALOG Hemodialysis Equipment
  • Model / Serial
    710200L, 710200K, 710200S, 710200U, 710500L and 710500K, manufactured between April 1, 2013 and July 3, || 2013
  • Product Classification
    Gastroenterology-Urology Devices
  • Product Description
    Equipment indicated for hospital hemodialysis. You can use and store different profiles for different profiles for different parameters such as: UF, sodium, carbonate, heparin, dialysate flow and temperature.
  • Manufacturer
    B. Braun Avitum Ag

Manufacturer

B. Braun Avitum Ag