Events

Safety Alert for monitoring system for cardiopulmonary and circulatory variables

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

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
    I1501-2
  • Event Number
    2010EBC-0006455
  • Date
    2015-01-02
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=189
  • 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 there is a possibility that the sterility of the sensor may be compromised by problems in its primary packaging, leading to possible adverse events on patients.

Device

monitoring system for cardiopulmonary and circulatory variables
  • Model / Serial
    ProAQT sensors references PV8810, Lots 13JK21, 13KD13, 14AK20, 14AL20, 14BD10, 14CM25, 14EF08, || 14EK20 and 14FL25.
  • Product Description
    Determination and monitoring of cardiopulmonary and circulatory variables, through the thermodilution and pulmonary technique and continuously through the analysis of the pulse contour. Indicated in patients where cardiovascular and circulatory monitoring is necessary.
  • Manufacturer
    Pulsion Medical Systems SE

Manufacturer

Pulsion Medical Systems SE
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    NIDFSINVIMA