Freedom Driver System 의 안전성 경고

Safety alert

2018-02-28

2018-02-28

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20180228a.html

Medical device safety alert: syncardia freedom driver system the medicines and healthcare products regulatory agencies (mhra), united kingdom posted a field safety notice concerning syncardia freedom driver system used with the syncardia temporary total artificial heart (tah-t) [model number: 595000-001], manufactured by syncardia systems. the manufacturer is making changes to the manuals and labeling of the freedom driver system model no. 595000-001 that will strengthen existing warnings for users with regard to freedom driver drops, rough handling and exposure to liquid/debris. according to the manufacturer, the updates to the warnings in the freedom driver system manuals and labeling will enhance the safe use of the freedom driver system. if the freedom driver is dropped, exposed to liquid/debris or subjected to rough handling, it may sustain damage that will not allow it to provide life-sustaining functions as designed. serious injury or death could occur because of the failure of a freedom driver. in the event that a patient’s freedom driver is dropped, subjected to rough handling or exposed to liquid/debris, the patient must switch to the backup freedom driver. the manufacturer is conducting a voluntary field safety corrective action to reinforce these changes by informing freedom driver customers of the changes and ensuring that the clinical staff and patients review the changes and that the patients are trained on the new labeling. for details, please refer to the following mhra website: https://www.Gov.Uk/drug-device-alerts/field-safety-notice-19-to-23-february-2018 according to the manufacturer, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 28 february 2018.