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
    2012-01-04
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120104a.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
    Field safety notice: syncardia freedom driver system the uk medicines and healthcare products regulatory agency (mhra) issued a field safety notice to alert healthcare providers and customers regarding the freedom driver system manufactured by syncardia systems, inc. according to the manufacturer, a freedom driver supporting a patient in the united states exhibited intermittent low cardiac output alarms as a result of instances of elevated systolic blood pressure readings above 160mmhg. while all distributed freedom drivers are within specifications, some can support a higher level of transient instances of hypertension than others. the driver that is the subject of the event was less tolerant to these elevated pressures, resulting in the low co alarms. syncardia is replacing freedom drivers that are less tolerant of these types of events with drivers that are more tolerant of these types of elevated systolic pressures. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm if you are in possession of the affected products, please stop using them and contact your supplier for necessary actions.

Device

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

Manufacturer

SynCardia Systems