Events

Safety Alert for Freedom Driver Systems used with the SynCardia temporary Total Artificial Heart (TAH-t)

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
    2015-09-21
  • Event Date Posted
    2015-09-21
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150921.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 systems freedom driver systems used with the syncardia temporary total artificial heart (tah-t) the united states food and drug administration (fda) has issued an alert concerning freedom driver systems used with the syncardia temporary total artificial heart (tah-t). the affected products were manufactured from 3 november 2014 to 29 july 2015 and distributed from 10 november 2014 to 29 july 2015. the affected lot numbers and serial numbers are identified as follows: lot number: 85978 (serial numbers: 85978-001 through 85978-040) lot number: 85979 (serial numbers.: 85979-001 through 85979-040) the manufacturer is recalling the affected products as a specific part of the freedom driver drive mechanism may fail and cause the device to stop pumping. patients do not receive any advanced warning that the device may fail. if it does fail, a red light located in the center of the driver, towards the top, will stay red and a loud continuous alarm will sound. however, if the freedom driver stops pumping, the patient will lose consciousness almost immediately, which means that the warning light and alarm may not be helpful. the patient will likely experience serious injury or death if not immediately switched to a backup driver by a caregiver. for details, please refer to the fda websites:http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm463300.Htm http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm463318.Htm the manufacturer is now replacing the affected drivers with new ones. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 21 september 2015.

Device

Freedom Driver Systems used with the SynCardia temporary Total Artificial Heart (TAH-t)
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: SynCardia Systems Freedom Driver Systems used with the SynCardia temporary Total Artificial Heart (TAH-t)
  • Manufacturer
    SynCardia Systems

Manufacturer

SynCardia Systems