BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCARDIA FREEDOM DRIVER

    MDR report key: 6011973 · Received October 7, 2016

    Report

    Report Number
    3003761017-2016-00329
    Event Type
    Injury
    Date Received
    October 7, 2016
    Date of Event
    September 8, 2016
    Report Date
    September 8, 2016
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    UDI-DI
    00858000003121
    PMA / PMN Number
    P030011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FREEDOM DRIVER WAS RETURNED TO SYNCARDIA FOR EVALUATION. VISUAL INSPECTION OF THE EXTERNAL AND INTERNAL COMPONENTS REVEALED NO ABNORMALITIES. REVIEW OF THE ALARM HISTORY (EEPROM) REVEALED AN ALARM THAT LIKELY RESULTED FROM A DRIVER EXCHANGE. ONLY PERMANENT FAULT ALARMS ARE RECORDED IN THE ALARM HISTORY. INTERMITTENT AND RECOVERABLE ALARMS, SUCH AS BATTERY ALARMS, TEMPERATURE ALARMS, OR FAULT ALARMS THAT ARE RESOLVED WITHIN THEIR CORRESPONDING RECOVERY DURATION, ARE NOT RECORDED IN THE EEPROM. THE DRIVER WAS TESTED AND MET ALL TEST ACCEPTANCE CRITERIA, WHICH INCLUDED NORMOTENSIVE AND HYPERTENSIVE PATIENT SIMULATOR SETTINGS, WITH NO ANOMALIES OR UNINTENDED ALARMS. THE REPORTED FAULT ALARM WAS NOT FUNCTIONALLY REPRODUCED DURING TESTING. THE FREEDOM DRIVER PERFORMED AS INTENDED, AND THERE WAS NO EVIDENCE OF A DEVICE MALFUNCTION. THE REPORTED ISSUE POSED A LOW RISK TO THE PATIENT BECAUSE THE FREEDOM DRIVER CONTINUED TO PERFORM ITS LIFE-SUSTAINING FUNCTIONS. THIS ISSUE WILL CONTINUE TO BE MONITORED AND TRENDED AS PART OF THE CUSTOMER EXPERIENCE PROCESS. SYNCARDIA HAS COMPLETED ITS EVALUATION OF THIS COMPLIANT AND IS CLOSING THIS FILE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PATIENT PARTICIPATED IN PHYSICAL THERAPY EARLY ON (B)(6) 2016 AND THEY PERFORMED DEEP TISSUE MANIPULATION ON HIS HIP, AFTER WHICH THE PATIENT REPORTED THAT HE DIDN'T FEEL WELL BUT HIS SYMPTOMS WERE NOT WELL DEFINED. THE CUSTOMER ALSO REPORTED THAT ON (B)(6) 2016 FREEDOM DRIVER S/N (B)(4) EXHIBITED INTERMITTENT FAULT ALARMS (MFR. REPORT # 3003761017-2016-00322) AND THE PATIENT FELT LIKE THE FREEDOM DRIVER WASN'T WORKING AND SWITCHED TO HIS BACKUP FREEDOM DRIVER S/N (B)(4). THE CUSTOMER ALSO REPORTED THAT AT 3:30 AM ON (B)(6) 2016 FREEDOM DRIVER S/N (B)(4) EXHIBITED A CONTINUOUS FAULT ALARM (MFR. REPORT # 3003761017-2016-00328) AND THE PATIENT WAS UNRESPONSIVE. THE PATIENT WAS SWITCHED TO HIS BACKUP FREEDOM DRIVER S/N (B)(4) AND REGAINED CONSCIOUSNESS. THE PATIENT WAS INSTRUCTED TO COME TO THE EMERGENCY ROOM AT (B)(6). THE CUSTOMER ALSO REPORTED THAT DURING THE CAR RIDE TO (B)(6), FREEDOM DRIVER S/N (B)(4) EXHIBITED A FAULT ALARM (MFR. REPORT # 3003761017-2016-00329), HOWEVER THE PATIENT DID NOT SWITCH DRIVERS BECAUSE THE OTHER TWO FREEDOM DRIVERS THEY HAD WITH THEM HAD ALREADY EXHIBITED FAULT ALARMS. THE PATIENT WAS AWAKE AND ALERT DURING THE CAR RIDE AND ARRIVED AT (B)(6) WITH FREEDOM DRIVER S/N (B)(4) EXHIBITING A FAULT ALARM. THE CUSTOMER ALSO REPORTED THAT AFTER THE PATIENT ARRIVED IN THE EMERGENCY ROOM AT 5:00 AM FREEDOM DRIVER S/N (B)(4) THEN WENT INTO A CONTINUOUS FAULT ALARM AND THE PATIENT STARTED TO LOSE CONSCIOUSNESS. THE PATIENT WAS SWITCHED FROM FREEDOM DRIVER S/N (B)(4) TO A COMPANION 2 DRIVER AND HE REGAINED CONSCIOUSNESS. THE CUSTOMER ALSO REPORTED THAT ALL THREE FREEDOM DRIVERS CONTINUED PUMPING DURING THEIR ALARMS. THE CUSTOMER ALSO REPORTED THAT ON (B)(6) 2016 A CT ANGIOGRAM WAS PERFORMED ON THE PATIENT AND A PULMONARY EMBOLISM WAS CONFIRMED. THE CUSTOMER ALSO REPORTED THAT THEY BELIEVE THE FAULT ALARMS WERE CAUSED BY PATIENT CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663383 SYNCARDIA FREEDOM DRIVER EXTERNAL PNEUMATIC DRIVER LOZ SYNCARDIA SYSTEMS, LLC 00858000003121

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization| R