BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE HVAD SYSTEM

    MDR report key: 14415714 · Received May 17, 2022

    Report

    Report Number
    14415714
    Event Type
    Death
    Date Received
    May 17, 2022
    Date of Event
    March 10, 2022
    Report Date
    April 26, 2022
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT ACCIDENTALLY UNPLUGGED UNIT FROM POWER AND VENTRICULAR ASSIST DEVICE (VAD) STOPPED ALARM REQUIRING A CONTROLLER EXCHANGE. PATIENT WAS ADVISED TO CHANGE CONTROLLER. THE CONTROLLER EXCHANGE WAS DONE SUCCESSFULLY, HOWEVER THE PUMP DID NOT RESTART. PATIENT WAS ASKED TO LOOK AT THE CONTROLLER AND THE RPMS WOULD GO FROM 0 UP TO 500 AND BACK DOWN TO 0 AND AFTER MULTIPLE ATTEMPTS TO START THE "VAD STOPPED ALARM CHANGE CONTROLLER ALARM."

    Description of Event or Problem · 0

    PATIENT ACCIDENTALLY UNPLUGGED UNIT FROM POWER AND VENTRICULAR ASSIST DEVICE (VAD) STOPPED ALARM REQUIRING A CONTROLLER EXCHANGE. PATIENT WAS ADVISED TO CHANGE CONTROLLER. THE CONTROLLER EXCHANGE WAS DONE SUCCESSFULLY, HOWEVER THE PUMP DID NOT RESTART. PATIENT WAS ASKED TO LOOK AT THE CONTROLLER AND THE RPMS WOULD GO FROM 0 UP TO 500 AND BACK DOWN TO 0 AND AFTER MULTIPLE ATTEMPTS TO START THE "VAD STOPPED ALARM CHANGE CONTROLLER ALARM." NOTES FROM CLINICAL TEAM IN RESPONSE TO MEDICAL DEVICE FAILURE BELOW. PATIENT CALLED OUR VAD EMERGENCY LINE WITH A "VAD STOPPED ALARM REQUIRING A CONTROLLER EXCHANGE." PATIENT WAS ADVISED TO CHANGE CONTROLLER. THIS WAS DONE SUCCESSFULLY HOWEVER THE PUMP DID NOT RESTART. PATIENT WAS ASKED TO LOOK AT THE CONTROLLER AND THE RPMS WOULD GO FROM 0 UP TO 500 AND BACK DOWN TO 0 AND AFTER MULTIPLE ATTEMPTS TO START THE "VAD STOPPED ALARM CHANGE CONTROLLER ALARM." PATIENT WAS ADVISED TO CALL 911. HEALTHCARE PROVIDER SPOKE TO PARAMEDICS VIA THE PHONE. IV STARTED. PATIENT IN ST RHYTHM AND SPEAKING FULL SENTENCES AND NOT DIAPHORETIC. THEY WERE ADVISED TO HAVE EPI DRIP AND EPI IVP AVAILABLE IN CASE LEVEL OF CONSCIOUSNESS (LOC) REDUCES AND BE TRANSPORTED IMMEDIATELY TO EMERGENCY ROOM FOR AN EMERGENT PUMP EXCHANGE. "LVAD STOPPED. PATIENT WAS ATTACHED TO OUR TABLET. LVAD WAS AT 0 FLOW AND 0RPMS. LVAD WAS STOPPED ON THE TABLET AND RESTARTED AND RPMS WOULD INCREASED UP TO 280 AND 300 AND THEN TURN TO 0 RPMS AND CYCLE THRU THIS AFTER MULTIPLE RESTARTS. LVAD WOULD NOT RESTART. DOCTOR WAS NOTIFIED AND PATIENT TO HAVE EMERGENT LVAD PUMP EXCHANGE. RISKS AND BENEFITS WERE EXPLAINED TO THE PATIENT AND MOTHER AT THE BESIDE AND CONSENT SIGNED AND THEY AGREED TO PROCEED. QUESTIONS AND CONCERNS ADDRESSED. WHEN PATIENT WAS ASKED WHAT EVENTS LEAD UP TO THE ¿VAD STOPPED¿ ALARM. THE PATIENT STATED HE WAS IN HIS CAR WITH HIS MOM AND SISTER. HIS CONTROLLER HAD A BATTERY ATTACHED AS A POWER SOURCE AND HE HAD HIS SECOND POWER SOURCE AS THE DC ADAPTER IN HIS CAR. HE HAD JUST TURNED HIS CAR OFF THEREFORE THE SECOND POWER SOURCE WITH THE DC ADAPTER WAS NO LONGER POWERING HIS CONTROLLER. HIS VAD WAS BEING POWERED BY THE ONE BATTERY ATTACHED TO THE CONTROLLER. THEN, HE ACCIDENTLY DISCONNECTED THE BATTERY POWERING HIS CONTROLLER WHICH INTERRUPTED POWER TO THE CONTROLLER BRIEFLY. HE IMMEDIATELY ATTACHED THE BATTERY TO THE CONTROLLER TO REESTABLISH POWER TO THE CONTROLLER AND HE RECEIVED THE ¿VAD STOPPED, CHANGE CONTROLLER¿ ALARM AND PROCEEDED TO CALL OUR VAD EMERGENCY LINE IMMEDIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1898790 HEARTWARE HVAD SYSTEM VENTRICULAR (ASSIST) BYPASS DSQ MEDTRONIC, INC. 1103

    Patients

    Seq Age Sex Outcome Treatment
    1 14235 DA Male Death