Events

Field Safety Notices about CytoSorb® 300 ml

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by CytoSorbents.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    In addition to extreme caution, this safety notice also informs you of the potential incompatibility of cytosorb®300 ml and inhaled anesthesia gas, nitrous oxide (n2o). this combination was associated with the death of three pigs in animal studies and the use of cytosorb® 300 ml for the intended purpose, which has not yet been ce marked. to our knowledge, no such adverse events have been reported in human treatment with regard to the combination of cytosorb® 300 ml nitrous oxide (n2o).

Device

CytoSorb® 300 ml

Manufacturer

CytoSorbents