Events

Safety Alert for thoracic drains Atrium

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

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
    I1612-584
  • Event Number
    2008DM-0001833
  • Date
    2016-12-16
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=108
  • 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 the deadvertence labels are being revised for the labeling of the chest drains, in order to inspect the current configuration of the container, clarifying that part of it is sterile, the affected product is packaged with a sterile double sequential wrap, a cover is placed external protective dust, and then bends and secures with the packaging label, the drain is sterile inside the container but the external dust cover is not, leading to possible serious adverse events on the patient.

Device

thoracic drains Atrium
  • Model / Serial
  • Product Description
    ATRIUM thoracic drains are non-invasive disposable systems of multi-chamber vessels with valves, port and suction regulators, fluid or air collection chamber, vacuum and leakage indicators and suction connectors designed to: evacuate fluids or air from the chest cavity or mediastinomediante succión and collect them in the container or chamber ofdesecho. Help restore the lungs expansion and restore respiratory dynamics, by means of the achieved drainage. Facilitate the early evaluation of postoperative patients who require chest drainage, through the achieved drainage.
  • Manufacturer
    Atrium Medical Corporation

Manufacturer

Atrium Medical Corporation
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    NIDFSINVIMA