BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE XVE LVAS

    MDR report key: 660665 · Received January 6, 2006

    Report

    Report Number
    2916596-2006-00004
    Event Type
    Death
    Date Received
    January 6, 2006
    Date of Event
    December 7, 2005
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DESTINATION THERAPY PATIENT WAS IMPLANTED WITH A VENTED ELECTRIC LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PATIENT HAD CALLED INTO THE HOSPITAL, AND STATED THAT THE DEVICE HAD DISPLAYED FREQUENT YELLOW WRENCH ALARMS AND AN ALLEGED RED HEART ALARM. THE VAD COORDINATOR INSTRUCTED THE PATIENT TO COME TO THE HOSPITAL FOR ADMISSION, AS SHE WAS ON THE SURGICAL SCHEDULE FOR A PUMP EXCHANGE FOR THE FOLLOWING WEEK. THE PATIENT WAS ADMITTED TO ICU. PER VAD COORDINATOR, WAVE FORMS WERE NOT OBTAINED AND THEY ATTEMPTED TO CHANGE THE SYSTEM CONTROLLER. THE PATIENT WAS IMMEDIATELY STARTED ON THE IP DRIVE CONSOLE WITH THE STROKE VOLUME LIMITER (SVL) AND A HEPARIN DRIP WAS STARTED AS THEY ATTRIBUTED THE PROBLEM TO PUMP FAILURE. THE PATIENT WAS STILL SCHEDULED FOR A PUMP EXCHANGE FOR THE FOLLOWING WEEK. OF NOTE, THE PATIENT HAS HAD A PUMP POCKET INFECTION AND HAS HAD 2 JP DRAINS IN PLACE AND WAS CURRENTLY RECEIVING ANTIBIOTICS AND ANTI FUNGALS. A FEW DAYS LATER THE VAD COORDINATOR E-MAILED THE MANUFACTURER WITH UPDATED INFORMATION ON THE PATIENT. THE PATIENT HAD A MOTTLED LEFT ARM, HEMIPARESIS, AND ELEVATED LACTATE, AND IS NOW REINTUBATED, AND ELEVATED TROPONIN. THE PATIENT'S OVERALL PROGNOSIS WAS VERY POOR. LATER THAT DAY THE MANUFACTURER SPOKE WITH THE VAD COORDINATOR BY PHONE, AND SHE STATED THAT THE PLAN WAS TO WITHDRAW LIFE SUPPORT. THE VAD COORDINATOR DOES NOT BELIEVE THAT THE FAMILY WILL AGREE TO A POST MORTEM EXAM AND THE PUMP WILL MOST LIKELY NOT BE RETURNED TO MANUFACTURER FOR ANALYSIS. THE PATIENT'S DEATH WAS LISTED AS CARDIOGENIC SHOCK. THE PATIENT HAD A VERY INVOLVED HEALTH HISTORY THAT INCLUDED LUNG CANCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE XVE LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 1270 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death