BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA FREEDOM DRIVER

    MDR report key: 4032054 · Received August 4, 2014

    Report

    Report Number
    3003761017-2014-00112
    Event Type
    Malfunction
    Date Received
    August 4, 2014
    Date of Event
    July 18, 2014
    Report Date
    August 1, 2014
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PATIENT HAD SWITCHED FROM HIS PRIMARY FREEDOM DRIVER TO HIS BACKUP FREEDOM DRIVER WHEN HE EXPERIENCED HIGH FILL VOLUMES (SEE MFR REPORT 3003761017-2014-00110). THE CUSTOMER ALSO REPORTED THAT WHEN THE PATIENT SWITCHED TO THE BACKUP FREEDOM DRIVER, HE CONTINUED TO EXPERIENCE HIGH FILL VOLUMES AND SAID HE FELT "LIKE HE DOES WHEN HE HAS AN ADRENALINE SURGE AND KNOWS HE NEEDS TO CALM HIMSELF DOWN." THE PATIENT WAS SWITCHED TO ANOTHER BACKUP FREEDOM DRIVER WITHOUT ADVERSE IMPACT AND NO LONGER EXPERIENCED HIGH FILL VOLUMES. THIS ALLEGED FAILURE MODE POSES A LOW RISK TO THE PATIENT BECAUSE IT DOES NOT PREVENT THE FREEDOM DRIVER FROM PERFORMING ITS LIFE-SUSTAINING FUNCTIONS. ALTHOUGH THE PATIENT EXPERIENCED HIGH FILL VOLUMES, THE FREEDOM DRIVER CONTINUED TO FUNCTION AS INTENDED. AN INVESTIGATION WILL BE CONDUCTED BY SYNCARDIA AND THE RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453375 SYNCARDIA FREEDOM DRIVER CIRCULATORY ASSIST DEVICE LOZ SYNCARDIA SYSTEMS, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR