BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCARDIA FREEDOM DRIVER

    MDR report key: 7041647 · Received November 17, 2017

    Report

    Report Number
    3003761017-2017-00206
    Event Type
    Injury
    Date Received
    November 17, 2017
    Date of Event
    October 20, 2017
    Report Date
    October 20, 2017
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    UDI-DI
    00858000003121
    PMA / PMN Number
    P030011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FREEDOM DRIVER WAS RETURNED TO SYNCARDIA FOR EVALUATION. THE CUSTOMER-REPORTED ISSUE OF INTERMITTENT ALARMS FOR LOW CARDIAC OUTPUT COULD NOT BE CONFIRMED, AS THE DRIVER'S ALARM HISTORY DOES NOT RECORD INTERMITTENT OR RECOVERABLE ALARMS. THE DRIVER IN "AS RECEIVED" CONDITION PASSED ALL INCOMING FUNCTIONAL TEST REQUIREMENTS WITH NO ISSUES OR ALARMS. AN EXTENDED OBSERVATION RUN WAS PERFORMED ON A 50 CC MOCK TANK, DURING WHICH THE DRIVER PERFORMED AS INTENDED WITH NO UNINTENDED ALARMS OR ANOMALIES. THE MOCK TANK WAS THEN SET TO HYPOVOLEMIC SETTINGS, AND UNDER THESE CIRCUMSTANCES WHEN CARDIAC OUTPUT DECREASED BELOW 3.5 LPM, THE FREEDOM DRIVER EXHIBITED A LOW CARDIAC OUTPUT ALARM AS DESIGNED. THE CUSTOMER-REPORTED LOW CARDIAC OUTPUT ALARM WAS REPRODUCED. A POSSIBLE CAUSE FOR THE REPORTED ALARM EXPERIENCED BY THE PATIENT COULD BE ATTRIBUTED TO THE PATIENT CONDITIONS. AN ALARM FOR LOW CARDIAC OUTPUT (BELOW 3.5 LPM) WOULD NOT RECORD AS A FAULT ALARM IN THE DRIVER ALARM HISTORY UNTIL 4 MINUTES, 15 SECONDS OF CONTINUOUS ALARM CONDITIONS WITHOUT RESOLVE. THERE IS NO EVIDENCE OF AN ALARM RELATED TO LOW CARDIAC OUTPUT RECORDED IN THE DRIVER'S ALARM HISTORY, AND IT IS NOT KNOWN IF THE PATIENT EXPERIENCED PROLONGED LOW CARDIAC OUTPUT CONDITIONS. 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) INITIAL.

    Description of Event or Problem · 1

    THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE FREEDOM DRIVER EXHIBITED INTERMITTENT LOW CARDIAC OUTPUT ALARMS WHILE SUPPORTING A PATIENT. THE CUSTOMER ALSO REPORTED THAT THE PATIENT'S FILL VOLUMES WERE MOSTLY IN THE HIGH 30S TO LOW 40S BUT WERE DROPPING INTO THE 20S ABOUT ONCE AN HOUR. THE CUSTOMER ALSO REPORTED THAT THE PATIENT HAD STOPPED DIURETICS AND HER BEAT RATE HAD RECENTLY BEEN ADJUSTED TO 135 BPM. THE CUSTOMER ALSO REPORTED THAT THE PATIENT RECEIVED 500 CC IVF IN TRANSIT TO HOSPITAL AND HAD NO MORE ALARMS FROM THE FREEDOM DRIVER. THE CUSTOMER ALSO REPORTED THAT THE PATIENT'S LABORATORY RESULTS DID NOT INDICATE THAT SHE WAS DRY, HOWEVER, PATIENT CONTINUED TO DRINK 2-3 LITERS OF GATORADE. THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS SUBSEQUENTLY SWITCHED TO A BACK-UP FREEDOM DRIVER WITHOUT ANY ADVERSE PATIENT IMPACT. THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS DISCHARGED LATER THE SAME DAY OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821588 SYNCARDIA FREEDOM DRIVER EXTERNAL PNEUMATIC DRIVER LOZ SYNCARDIA SYSTEMS, LLC 595000-001 00858000003121

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention