Events

Safety Alert for Intra-aortic balloon pump CS300

According to National Drugs Administration from El Salvador (DNM), this safety alert involved a device in El Salvador that was produced by Maquet.

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 Risk Class
    Class I
  • Date
    2017-06-16
  • Event Country
    El Salvador
  • Event Source
    DNM
  • Event Source URL
    https://www.medicamentos.gob.sv/index.php/es/servicios-m/ciudadanos/alertas-dnm/alertas-sanitarias-internacionales
  • Notes / Alerts
    Data from El Salvador is current through April 2018. All of the data comes from the National Drugs Administration from El Salvador (DNM), 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 data from the U.S. and El Salvador.
  • Extra notes in the data
  • Reason
    The cause of the sanitary wing is due to a valve failure that prevents the balloon from inflating and deflating properly. if a patient requires circulatory support with an iabp (balloon intra-aortic pump) and the device does not work, or if the treatment is stopped during use without a replacement iabp available, device failure may result in immediate adverse consequences and serious for health, including death. the sanitary registry im011319012017 covers the model cs300 visits the distributor's facilities and requested documentation of imports and stocks, where it was stated that no related imports had been made since 2012 and that the company's knowledge said affected equipment are outside of uses since they were replaced by more recent technology in 2016.
  • Action
    Professionals and health centers are advised to stop immediately using the products described in the health alert and to demand from the supplier of the same the action plan to solve said defect or the withdrawal of the product. Notice to the population recomending not to use the product and inform the National Drugs Administration about the commercialization, distribution or dispensation of this product within any health establishment. - Make searches of the product in health centers and establishments that are dedicated to the sale of medical devices

Device

Intra-aortic balloon pump CS300

Manufacturer

Maquet
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    NDAESDNM