BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART

    MDR report key: 3143103 · Received May 30, 2013

    Report

    Report Number
    3003761017-2013-00058
    Event Type
    Injury
    Date Received
    May 30, 2013
    Date of Event
    May 11, 2013
    Report Date
    May 29, 2013
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT STILL IMPLANTED. THE CUSTOMER REPORTED THAT THE CANNULAE WERE CONNECTED TO THE DRIVELINES AFTER APPROXIMATELY 60-90 SECONDS. THE PATIENT'S PULSE RETURNED BUT HE WAS NOT BREATHING, SO HE WAS VENTILATED VIA AMBU BAG. THE PATIENT BECAME RESPONSIVE AND WAS BREATHING ON HIS OWN PRIOR TO EMERGE INTUBATION. THE CUSTOMER ALSO REPORTED THAT INITIALLY, THE PATIENT STATED THAT HE HAD NO RECOLLECTION OF HOW THE CANNULAE BECAME DISCONNECTED. HOWEVER, AFTER A PERIOD OF TIME, HE STATED THAT THE CANNULAE BECAME DISCONNECTED WHEN HE STRETCHED OUT HIS FEET. THE CUSTOMER REPORTED THAT THE PATIENT IS NEUROLOGICALLY INTACT AND THAT HIS VITAL SIGNS ARE STABLE. HOWEVER, HIS WIFE REPORTED THAT THE PATIENT IS WEAK AND SHE FEELS THAT HIS OVERALL STATUS HAD DECLINED OVER THE PAST FEW WEEKS. THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION THAT CAUSED THE DISCONNECTION OF THE TAH-T CANNULAE FROM THE DRIVER DRIVELINES. SYNCARDIA HAS COMPLETED IT'S EVALUATION OF THIS COMPLAINT AND IS CLOSING THIS FILE.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH THE SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) ON (B)(6) 2012. HE WAS SUBSEQUENTLY ENROLLED IN THE FREEDOM DRIVER SYSTEM IDE STUDY. AT THE TIME OF THE REPORTED ISSUE, THE PATIENT WAS IN THE HOSPITAL, SUPPORTED BY A FREEDOM PORTABLE DRIVER. THE CUSTOMER REPORTED THAT THE PATIENT UNDERWENT HEMODIALYSIS ON THE MORNING OF (B)(6) 2013. THE FREEDOM DRIVER EXHIBITED APPROXIMATELY THREE SELF-LIMITING FAULT ALARMS DURING DIALYSIS. THE CAUSE OF THE ALARMS WAS UNDETERMINED, NO AUDIBLE OR TACTILE AIR LEAK WAS NOTED FROM THE TAH-T CANNULAE, AND THE WIRE TIES ON THE CANNULAE WERE OBSERVED AND FOUND TO BE SECURE. THE CUSTOMER ALSO REPORTED THAT IN THE AFTERNOON, SHORTLY AFTER THE PATIENT'S WIFE LEFT THE PATIENT'S ROOM, THE FREEDOM DRIVER EXHIBITED A FAULT ALARM. WHEN THE NURSE RESPONDED TO THE PATIENT'S ROOM, THE PATIENT WAS FOUND UNRESPONSIVE IN A CHAIR, AND TAH-T CANNULAE WERE DISCONNECTED FROM THE MALE AND FEMALE CONNECTORS, AND THE DRIVER DRIVELINES WERE LYING ON THE FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239984 SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART ARTIFICIAL HEART LOZ SYNCARDIA SYSTEMS, INC. TAH-T 071284

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention