Events

Safety Alert for CytoSorb 300 mL Device

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by CytoSorbents.

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
  • Date
    2016-01-12
  • Event Date Posted
    2016-01-12
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160112b.html
  • Notes / Alerts
    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.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    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
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: CytoSorbents CytoSorb 300 mL Device
  • Manufacturer
    CytoSorbents

Manufacturer

CytoSorbents