Events

Safety Alert for Solution for Dialysis in Renal Replacement Therapy

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

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
    R1607-274
  • Event Number
    2010DM-0005701
  • Date
    2016-07-07
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=133
  • 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 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
  • Model / Serial
    105351 - PRISMASATE BGK 2/0, lots 1000123133 and 1000128162 distributed between 10/27/2015 and 01/30/2016.
  • Product Description
    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.