CytoSorb 300 mL Device 의 안전성 경고

Safety alert

2016-01-12

2016-01-12

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20160112b.html

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.