BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE HVAD CONTROLLER

    MDR report key: 8070638 · Received November 13, 2018

    Report

    Report Number
    MW5081236
    Event Type
    Malfunction
    Date Received
    November 13, 2018
    Date of Event
    October 12, 2018
    Report Date
    November 6, 2018
    Manufacturer
    HEARTWARE INC / MEDTRONIC INC.
    Product Code
    DSQ
    UDI-DI
    00888707000420
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT ARRIVED TO EC FOR C/O HEADACHES. CIRC SUPPORT COORDINATOR AT BEDSIDE TO PLUG PT'S LVAD TO OUR CAPITAL MONITOR AND THE AC ADAPTER PER PROTOCOL. SHORTLY AFTER PLUGGING THE LVAD INTO THE AC ADAPTER, THE LVAD ALARMED WITH THE MESSAGE "2ND POWER DISCONNECTED." THE CIRC SUPPORT COORDINATOR THEN CONNECTED THE LVAD BACK TO PT'S 2 BATTERIES AND STILL GOT THE ALART "2ND BATTERY DISCONNECTED." DECISION MADE TO PERFORM A CONTROLLER EXCHANGE AND SYSTEM DISPLAYED THE SAME MESSAGE. COORDINATOR CONTACTED ANOTHER HEART FAILURE MD AND REACHED OUT TO THE DEVICE'S REP WHO CAME TO THE PT'S BEDSIDE TO ANALZYE/TROUBLE SHOOT FURTHER. AT THAT TIME, ANOTHER CONTROLLER EXCHANGE WAS PERFORMED USING BOTH BATTERY SOURCES INSTEAD OF THE AC ADAPTER AND CONTROLLER EXCHANGED WORKED EFFICIENTLY WITH BOTH BATTERIES PROVIDING SUPPORT. THE PT HAD TO REMAIN ON HER BATTERY FOR THE DURATION OF THE VISIT IN ED. ED ELECTRICAL SUPPLY IN ON MONITORED POWER SUPPLY. NO DEVIATIONS NOTED UPON REVIEW OF THE POWER SUPPLY. HEARTWARE MEDICAL POWER SUPPLY, (B)(4), HEARTWARE HVAD CONTROLLER REF (B)(4), SN (B)(4), HEARTWARE MEDICAL POWER SUPPLY(B)(4), HEARTWARE HVAD CONTROLLER REF (B)(4) SN (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902469 HEARTWARE HVAD CONTROLLER VENTRICULAR ASSIST BYPASS DSQ HEARTWARE INC / MEDTRONIC INC. 1420 00888707000420
    902470 HEARTWARE HVAD CONTROLLER VENTRICULAR ASSIST BYPASS DSQ HEARTWARE INC / MEDTRONIC INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR