Events

Safety Alert for oxygenator system - Quadrox-I, reservoir - VHK and filter - Quart

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Maquet Cardiopulmonary A. G. || Maquet Cardipulmonary- Medikal T.

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
    I1503-135
  • Event Number
    2013DM-0010086
  • Date
    2015-03-20
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=182
  • 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 a blood leak in the desalted port (area of the lowest part of the oxygenator), leading to potentially adverse events occurring to patients or users due to blood exposure.

Device

oxygenator system - Quadrox-I, reservoir - VHK and filter - Quart
  • Model / Serial
    QUADROX-I, concerning the HLS Advanced Set, Adult Diffusion Membrane, Small Adult Diffusion Membrane and || Set PLS.
  • Product Description
    System indicated to be used during cardiopulmonary bypass in extracorporeal cardiocirurgical interventions where the system allows to eliminate and eliminate carbon dioxide from the blood and to adjust the blood temperature, which together with the reservoir, collects, stores and filters the blood.
  • Manufacturer
    Maquet Cardiopulmonary A. G. || Maquet Cardipulmonary- Medikal T

Manufacturer

Maquet Cardiopulmonary A. G. || Maquet Cardipulmonary- Medikal T
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    NIDFSINVIMA