BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART SYSTEM

    MDR report key: 7236942 · Received February 2, 2018

    Report

    Report Number
    7236942
    Event Type
    Injury
    Date Received
    February 2, 2018
    Date of Event
    September 16, 2016
    Report Date
    January 26, 2018
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED TO CCU (CARDIAC CARE UNIT) FOLLOWING EPISODE OF LOC (LOSS OF CONSCIOUSNESS) AND PALPITATIONS WITH CT ANGIO CHEST. CT WAS SIGNIFICANT FOR ACUTE PE (PULMONARY EMBOLISM). THERE WAS CONCERN FOR A POSSIBLE THROMBUS CAUSING TAH (TOTAL ARTIFICIAL HEART) ALARMS. DRIVER CHANGED AND SO FAR EVERYTHING OK. WE HAVE ORDERED A SECOND BACKUP DRIVER TO BE DELIVERED TODAY TO HAVE AT BEDSIDE. RECURRENT DEVICE ALARMS SECONDARY TO PE REQUIRED MULTIPLE VISITS TO THE BEDSIDE FOR ACTIVE TITRATION OF VASOACTIVE DRIPS AND DEVICE INTERROGATION WITH HIGH POTENTIAL FOR HEMODYNAMIC INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82207 SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART SYSTEM ARTIFICIAL HEART LOZ SYNCARDIA SYSTEMS, LLC 500101-001

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Life Threatening DIALYSIS| OTHER, HEPARIN AND NITROUS OXIDE AND CVVHD| TOTAL ARTIFICIAL HEART AND DIALYSIS FOR ESRD.