BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 6074737 · Received November 2, 2016

    Report

    Report Number
    2916596-2016-02141
    Event Type
    Death
    Date Received
    November 2, 2016
    Date of Event
    October 8, 2016
    Report Date
    July 18, 2017
    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

    THE REPORT OF LOW FLOW ALARMS AND A PUMP STOP DUE TO DISCONNECTION OF THE DRIVELINE WAS CONFIRMED THROUGH THE ANALYSIS OF THE SUBMITTED SYSTEM CONTROLLER LOG FILE. ON (B)(6) 2016 AT 10:23, THE SYSTEM CONTROLLER BEGAN CAPTURING LOW FLOW HAZARD ALARMS WHICH CONTINUED INTERMITTENTLY UNTIL THE DRIVELINE WAS DISCONNECTED FROM THE SYSTEM CONTROLLER ON (B)(6) 2016 AT 12:00, CAUSING THE PUMP TO STOP. THE DRIVELINE REMAINED DISCONNECTED FOR 43 MINUTES. FOLLOWING THE PUMP STOP, THE PUMP APPEARED TO RESUME OPERATING NORMALLY. A SPECIFIC CAUSE FOR THE OBSERVED LOW FLOW ALARMS COULD NOT BE CONCLUSIVELY DETERMINED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). APPROXIMATE AGE OF DEVICE - 1 YEAR, 8 MONTHS. ADDITIONAL INFORMATION WAS NOT PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. IT WAS REPORTED THAT THE CIRCUMSTANCES OF THE EVENT WERE UNCLEAR. THE ASSUMPTION IS THAT THE PATIENT HAD A LOW FLOW ALARM WHILE AT HOME, POTENTIALLY DUE TO ARRHYTHMIA. THE POTASSIUM LEVEL WAS 1.8 MEQ/L AND THE MAGNESIUM 0.8 MEQ/L. THE PATIENT AND A NEIGHBOR ATTEMPTED TO CHANGE THE SYSTEM CONTROLLER IN RESPONSE TO THE ALARMS, BUT DID NOT RECONNECT THE DRIVELINE APPROPRIATELY. EMERGENCY SERVICES ARRIVED AND RECONNECTED THE DRIVELINE AFTER 38 MINUTES. THE PATIENT EXPERIENCED NEUROLOGIC DYSFUNCTION AND WAS INTUBATED. THE PATIENT UNDERWENT A HYPOTHERMIA PROTOCOL TO ATTEMPT TO PRESERVE BRAIN FUNCTION. THERE WAS NO IMPROVEMENT NEUROLOGICALLY AFTER THE PATIENT WAS RE-WARMED. THE PATIENT EXPIRED ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725027 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Death