Events

Alerte De Sécurité sur CytoSorb 300 mL Device

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par CytoSorbents.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2016-01-12
  • Date de publication de l'événement
    2016-01-12
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160112b.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: cytosorbents cytosorb 300 ml device the medicines and healthcare products regulatory agency (mhra) of united kingdom posted a medical device safety alert concerning cytosorb 300 ml device manufactured by cytosorbents. the manufacturer has identified a possible incompatibility of the cytosorb 300 ml device with the inhaled anaesthetic gas, nitrous oxide (n2o). this combination has been associated with the death of three pigs in animal studies using the cytosorb 300 ml device for an intended purpose for which it is not yet ce marked. to the manufacturer’s knowledge, there have been no such reported cases of adverse events relating to the combination of the cytosorb 300 ml device with n2o in treatment of humans. the manufacturer advises clinicians not to use cytosorb in combination with n2o under any circumstances until further notification from the manufacturer. the clinical scenario described is likely to be most relevant for patients that are undergoing surgery using n2o, which is relatively rare in modern surgical anaesthesia. for details, please refer to the mhra website:https://www.Gov.Uk/drug-device-alerts/field-safety-notices-4-january-to-8-january-2016 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 12 january 2016.

Device

CytoSorb 300 mL Device
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: CytoSorbents CytoSorb 300 mL Device
  • Manufacturer
    CytoSorbents

Manufacturer

CytoSorbents