BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 5806769 · Received July 19, 2016

    Report

    Report Number
    2916596-2016-01344
    Event Type
    Death
    Date Received
    July 19, 2016
    Date of Event
    June 15, 2016
    Report Date
    July 7, 2017
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). APPROXIMATE AGE OF DEVICE ¿ 4 MONTHS. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE LEFT VENTRICULAR ASSIST DEVICE WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE SUBMITTED SYSTEM CONTROLLER LOG FILE CONTAINED DATA SPANNING FROM (B)(6) 2016 14:40 TO (B)(6) 2016 10:13. LOW FLOW ALARMS WERE SCATTERED THROUGHOUT THE LOG FILE UNTIL (B)(6) 2016 AT 04:09 WHEN THE ESTIMATED PUMP FLOW VALUE DROPPED TO 0 LPM AND REMAINED AT 0 LPM FOR THE REMAINDER OF THE LOG FILE. ON (B)(6) 2016 AT 04:56, A LOW BATTERY ADVISORY ALARM BECAME ACTIVE AND LOW BATTERY HAZARD AND NO EXTERNAL POWER ALARMS BECAME ACTIVE AND THE EMERGENCY BACKUP BATTERY ALARM WAS ENGAGED. THE PUMP REMAINED IN POWER SAVE MODE UNTIL (B)(6) 2016 AT 10:13 WHEN THE EMERGENCY BACKUP BATTERY BECAME DEPLETED AND THE PUMP STOPPED. THE EVENTS CAPTURED IN THE LOG FILE ARE CONSISTENT WITH THE DEPLETION OF THE PATIENT'S BATTERIES, CAUSING THE PUMP TO STOP AND THE SYSTEM CONTROLLER TO RESET; HOWEVER, A SPECIFIC CAUSE FOR THE 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.

    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 EXPIRED IN THEIR BATHROOM. THE PATIENT HAD REPORTEDLY BEEN VERY STRESSED FROM PROVIDING CARE TO THEIR TERMINALLY ILL SPOUSE, MISSED SOME MEDICATION DOSAGES, AND HAD AN INR OF 4.2 A FEW DAYS PRIOR. A NEUROLOGICAL EVENT WAS SUSPECTED AS THE CAUSE OF DEATH. IT WAS REPORTED THAT THE LVAD SYSTEM WAS THOUGHT TO BE ALARMING FOR LOW BATTERY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457595 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death