BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA FREEDOM DRIVER

    MDR report key: 5998424 · Received October 4, 2016

    Report

    Report Number
    3003761017-2016-00333
    Event Type
    Malfunction
    Date Received
    October 4, 2016
    Date of Event
    September 24, 2016
    Report Date
    September 24, 2016
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    UDI-DI
    00858000003121
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ALLEGED FAILURE MODE POSES A LOW RISK TO THE PATIENT BECAUSE ALTHOUGH THE FREEDOM DRIVER EXHIBITED A FAULT ALARM, THE FREEDOM DRIVER CONTINUED TO PERFORM ITS LIFE-SUSTAINING FUNCTIONS. THE FREEDOM DRIVER WILL BE RETURNED TO SYNCARDIA FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A FOLLOW-UP MDR. (B)(4).

    Additional Manufacturer Narrative · 1

    THE FREEDOM DRIVER WAS RETURNED TO SYNCARDIA FOR EVALUATION. THE DRIVER IN "AS RECEIVED" CONDITION MET ALL TEST ACCEPTANCE CRITERIA, WHICH INCLUDED NORMOTENSIVE AND HYPERTENSIVE SETTINGS, WITH NO ANOMALIES OR ALARMS. THE DRIVER WAS FURTHER TESTED FOR A VALSALVA MANEUVER AT NORMOTENSIVE SETTINGS, AND THE DRIVER ALARMED AS INTENDED WHEN THE CARDIAC OUTPUT WAS UNDER 3.5 LMP, BUT RECOVERED AS EXPECTED WHEN CARDIAC OUTPUT INCREASED. THE DRIVER PERFORMED AS INTENDED DURING INVESTIGATION TESTING, AND THERE WAS NO EVIDENCE OF A DEVICE MALFUNCTION. THIS ISSUE WILL CONTINUE TO BE MONITORED AND TRENDED AS PART OF THE CUSTOMER EXPERIENCE PROCESS. SYNCARDIA HAS COMPLETED ITS EVALUATION OF THIS COMPLAINT AND IS CLOSING THE FILE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE FREEDOM DRIVER EXHIBITED A FAULT ALARM WHILE THE PATIENT WAS USING THE BATHROOM. THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS SUBSEQUENTLY SWITCHED TO THE BACKUP FREEDOM DRIVER. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE FREEDOM DRIVER EXHIBITED A FAULT ALARM WHILE THE PATIENT WAS USING THE BATHROOM. THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS SUBSEQUENTLY SWITCHED TO THE BACKUP FREEDOM DRIVER. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650377 SYNCARDIA FREEDOM DRIVER EXTERNAL PNEUMATIC DRIVER LOZ SYNCARDIA SYSTEMS, LLC 00858000003121

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR