BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA FREEDOM DRIVER

    MDR report key: 6059236 · Received October 26, 2016

    Report

    Report Number
    3003761017-2016-00352
    Event Type
    Malfunction
    Date Received
    October 26, 2016
    Date of Event
    October 12, 2016
    Report Date
    October 12, 2016
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    UDI-DI
    00858000003121
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 AN UNCLEAR RED ALARM, IT 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) INITIAL.

    Additional Manufacturer Narrative · 1

    THE FREEDOM DRIVER WAS RETURNED TO SYNCARDIA FOR EVALUATION. THE CUSTOMER-REPORTED ALARM WAS CONFIRMED THROUGH REVIEW OF THE DRIVER'S ALARM HISTORY BUT WAS NOT REPRODUCED DURING INVESTIGATION TESTING. THE 34 CODE ALARM CAN BE PRODUCED AS A RESULT OF AN ONBOARD BATTERY EXCHANGE WHILE OPERATING THE FREEDOM DRIVER ONLY ON BATTERY POWER, OR IF AN ONBOARD BATTERY WAS NOT FULLY LATCHED IN PLACE. AS DESCRIBED BY THE CUSTOMER, THE CUSTOMER WAS PREPARING TO DO A BATTERY EXCHANGE WHEN THEY PLUGGED THE DRIVER INTO THE AC POWER SUPPLY. THE AC POWER SUPPLY AND THE ONBOARD BATTERIES IN USE AT THE TIME OF THE CUSTOMER-REPORTED EXPERIENCE WERE NOT RETURNED AND THEREFORE COULD NOT BE EVALUATED. THE DRIVER PASSED ALL TEST SECTIONS AND PRESSURE PERFORMANCE METRICS ASSOCIATED WITH NORMOTENSIVE AND HYPERTENSIVE SETTINGS. ADDITIONALLY, AN EXTENDED OBSERVATION RUN WAS PERFORMED, DURING WHICH THE DRIVER FUNCTIONED AS INTENDED WITH NO ANOMALIES OR UNINTENDED ALARMS. 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 THIS FILE. (B)(4) FOLLOW-UP REPORT 1.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE FREEDOM DRIVER EXHIBITED AN UNCLEAR RED ALARM WHILE SUPPORTING A PATIENT. THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS SWITCHED TO A BACK-UP FREEDOM DRIVER WITHOUT ANY REPORTED ADVERSE IMPACT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE FREEDOM DRIVER EXHIBITED AN UNCLEAR RED ALARM WHILE SUPPORTING A PATIENT. THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS AT HOME CONNECTED TO FREEDOM DRIVER WHEN A BATTERY ALARM STARTED. THE PATIENT CONNECTED THE DRIVER TO THE AC POWER SUPPLY TO SWITCH AND CHARGE THE BATTERIES. IMMEDIATELY AFTER CONNECTING TO THE AC POWER SUPPLY, A FAULT ALARM STARTED. THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS SWITCHED TO A BACK-UP FREEDOM DRIVER WITHOUT ANY REPORTED ADVERSE PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709733 SYNCARDIA FREEDOM DRIVER EXTERNAL PNEUMATIC DRIVER LOZ SYNCARDIA SYSTEMS, LLC 595000-001 00858000003121

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR