Events

Avis De Sécurité sur CytoSorb® 300 ml

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par CytoSorbents.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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