BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE HVAD

    MDR report key: 12737898 · Received November 1, 2021

    Report

    Report Number
    MW5105062
    Event Type
    Injury
    Date Received
    November 1, 2021
    Date of Event
    October 16, 2021
    Report Date
    October 28, 2021
    Product Code
    DSQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2021 1950 (B)(6) STAFF CALLED LVAD HOTLINE WITH ON BEHALF OF PATIENT WHO SHOWED UP TO THEIR ED WITH HIS VAD ALARMING VAD STOPPED. PATIENT WAS STILL AWAKE AND ALERT SO AT THIS TIME THE (B)(6) ED STAFF WAS ASKED TO GIVE PHONE TO PATIENT SO PATIENT COULD BE WALKED THROUGH HVAD CONTROLLER CHANGE. PATIENT WALKED THROUGH CONTROLLER CHANGE UNEVENTFULLY. DISCUSSED SITUATION WITH PATIENT ONCE PUMP WAS RESTARTED AND ALARMS WERE SILENCED. PATIENT STATES HE WAS LEAVING A GATHERING WHEN HE HAD AN ALARM THAT INDICATED HE NEED TO CHANGE HIS BATTERY. HE DID THIS BUT THEN HIS ALARM DID NOT RESOLVE, SO HE CHANGED THE OTHER BATTERY AND NOTED THIS WAS NOT A BATTERY ALARM BUT A MORE SERIOUS ALARM. PATIENT HAD A FRIEND IMMEDIATELY DRIVE HIM TO THE CLOSEST ED, HE ESTIMATED HIS LVAD WAS STOPPED FOR ABOUT 30 MINUTES. PT ALSO REPORTS HE HAS A HVAD BATTERY WHICH THIS ALARM WAS HAPPENING WITH PREVIOUSLY THAT HE HAS TAKEN OUT OF SERVICE. THIS WAS A DEVICE FAILURE, MEDTRONIC WILL BE MADE AWARE AND WILL REQUEST EVALUATION OF EQUIPMENT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1632418 HEARTWARE HVAD VENTRICULAR (ASSIST) BYPASS DSQ

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening