Events

Safety Alert for Freedom Driver System

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

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
    2018-02-28
  • Event Date Posted
    2018-02-28
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180228a.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: 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.

Device

Freedom Driver System
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: SynCardia Freedom Driver System
  • Manufacturer
    SynCardia Systems

Manufacturer

SynCardia Systems