BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 6152958 · Received December 7, 2016

    Report

    Report Number
    2916596-2016-02369
    Event Type
    Death
    Date Received
    December 7, 2016
    Date of Event
    November 10, 2016
    Report Date
    November 10, 2016
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF DEVICE - 2 YEARS, 5 MONTHS. ADDITIONAL INFORMATION WAS NOT PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE REPORTED LOSS OF POWER TO THE SYSTEM CONTROLLER WAS CONFIRMED. REVIEW OF THE SUBMITTED SYSTEM CONTROLLER LOG FILE CONFIRMED THAT POWER WAS COMPLETELY DISCONNECTED FROM THE SYSTEM CONTROLLER TWICE AS INDICATED BY THE SYSTEM CLOCK RESETS RECORDED IN THE LOG FILE. THE PUMP RESUMED OPERATING AT THE SET SPEED WHEN THE SYSTEM CONTROLLER WAS RECONNECTED TO POWER. A CORRELATION BETWEEN THE DEVICE AND THE REPORTED HEMORRHAGIC STROKE COULD NOT BE CONCLUSIVELY DETERMINED. STROKE AND BLEEDING ARE LISTED IN THE INSTRUCTIONS FOR USE AS POTENTIAL ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED THAT THE PATIENT WAS FOUND DOWN FOR AN UNKNOWN PERIOD OF TIME. INTERROGATION OF THE SYSTEM CONTROLLER REVEALED A PUMP STOPPAGE AND LOW FLOW ALARM. THE PATIENT WAS DISCOVERED WITH BOTH POWER LEADS OF THE LVAD SYSTEM DISCONNECTED, POSSIBLY DUE TO PATIENT ERROR. THE FAMILY REPORTED THAT THE PATIENT HAD BEEN EXPERIENCING MORE FREQUENT ¿DEMENTIA LIKE¿ EPISODES AND PERIODS OF CONFUSION, PARTICULARLY EARLY IN THE MORNING. THE PATIENT SLEEPS IN A SEPARATE BEDROOM ALONE. THE SPOUSE HEARD THE LVAD ALARMING AND FOUND HIM DOWN ON THE FLOOR WITH THE LVAD SYSTEM CONTROLLER COMPLETELY DISCONNECTED FROM POWER. IT WAS REPORTED THAT IT APPEARED THAT THE PATIENT WAS ATTEMPTING TO SWITCH THE SYSTEM FROM THE POWER MODULE TO BATTERIES AND BECAME CONFUSED. THE PATIENT WAS NOT FOUND TO HAVE HAD ANY STROKE OR TRAUMA. DURING THE COMMUNICATION OF THE EVENT, IT WAS REPORTED THAT THE PATIENT EXPERIENCED A PRIOR HEMORRHAGIC STROKE REQUIRING A CRANIOTOMY THAT WAS PREVIOUSLY UNREPORTED TO THE MANUFACTURER. THE FAMILY SUBSEQUENTLY WITHDREW CARE AND THE PATIENT EXPIRED ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803930 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death