BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCARDIA TEMPORARY

    MDR report key: 2858825 · Received November 29, 2012

    Report

    Report Number
    3003761017-2012-00087
    Event Type
    Death
    Date Received
    November 29, 2012
    Date of Event
    November 21, 2012
    Report Date
    November 21, 2012
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THE TAH-T WILL BE RETURNED TO SYNCARDIA FOR EVAL. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH THE SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) ON (B)(6)2012, SUPPORTED BY A CIRCULATORY SUPPORT SYSTEM (CSS) CONSOLE. ON (B)(6) 2012, THE PT WAS SWITCHED TO A PORTABLE FREEDOM DRIVER, AND WAS SUBSEQUENTLY DISCHARGED TO HOME ON (B)(6) 2012. THE CUSTOMER REPORTED THAT ON (B)(6) 2012 AT 3:00 A.M., THE PT WAS BROUGHT TO AN OUTLYING HOSPITAL, (B)(6) HOSPITAL. HE HAD AN ALTERED MENTAL STATUS AND RECEIVED A CT SCAN, WHICH WAS NEGATIVE. WHILE THE PT WAS AT (B)(6) HOSPITAL, THE FREEDOM DRIVER DID NOT EXHIBIT ANY ALARMS. THE PT WAS TRANSFERRED TO (B)(6) MEDICAL CENTER AT 6:00 A.M. THE CUSTOMER REPORTED THAT DURING THE TRANSFER OF THE PT, THE FREEDOM DRIVER EXHIBITED A FAULT ALARM. THE ELAPSED TIME FROM ADMISSION TO (B)(6) HOSPITAL TO ADMISSION TO (B)(6) MEDICAL CENTER WAS 3.5 HOURS. THE CUSTOMER REPORTED THAT WHEN THE PT WAS ADMITTED TO (B)(6) MEDICAL CENTER, HE WAS HAVING TROUBLE BREATHING. THE PT WAS INTUBATED AND POSSIBLE SPUTUM WAS OBSERVED COMING OUT OF THE ET TUBE. THE PT'S BLOOD PRESSURE WAS 167/97. THE PT BECAME UNRESPONSIVE. THE CUSTOMER REPORTED THAT THE PT WAS SWITCHED TO A BACKUP FREEDOM DRIVER, BUT THERE WAS NO CHANGE IN PT STATUS. THE PT WAS THEN SWITCHED TO A CSS CONSOLE. THE CSS CONSOLE DRIVELINE PRESSURES WERE SET AT 200 ON THE LEFT SIDE AND 190 ON THE RIGHT SIDE. THE CUSTOMER REPORTED THAT THE FLOW WAVEFORMS SHOWED ON FLOW BEING GENERATED, THE FILL VOLUMES WERE AT ZERO AND THE CARDIAC OUTPUT WAS ZERO. THE EJECT WAVEFORMS SHOWED A PROLONGED PLATEAU, SUGGESTING THAT THERE WAS NO FLOW GOING THROUGH THE TAH-T AT THAT TIME. THE PT EXPIRED. THE CUSTOMER REPORTED THAT THEREAFTER, THE CSS CONSOLE WAS TESTED ON A MOCK CIRCULATION TANK (PT SIMULATOR) AND PERFORMED AS INTENDED, EXHIBITING NORMAL FLOW AND EJECT WAVEFORMS. THE CUSTOMER REPORTED THAT ON (B)(6) 2012, THE TAH-T WAS EXPLANTED. THE CUSTOMER ALSO REPORTED THAT HE OBSERVED A POSSIBLE TEAR OF THE DIAPHRAGM IN THE LEFT TAH-T VENTRICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCARDIA TEMPORARY ARTIFICIAL HEART LOZ SYNCARDIA SYSTEMS, INC. TAH-T 073893

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Death| H