BEUDAMED
    FDA Adverse Event Death Summary report: N

    NYTONE BEDWETTING ALARM

    MDR report key: 7957660 · Received October 10, 2018

    Report

    Report Number
    7957660
    Event Type
    Death
    Date Received
    October 10, 2018
    Date of Event
    October 3, 2018
    Report Date
    October 8, 2018
    Manufacturer
    NYTONE
    Product Code
    KPN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KS, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    ON THE MORNING OF (B)(6) 2018 DURING A NOCTURNAL HOME HEMODIALYSIS TREATMENT, THE PT'S ENURESIS ALARM SOUNDED, WAKING THE PT'S WIFE. THIS WAS APPROX 3.5 HOURS INTO THE SCHEDULED 5 HOUR TREATMENT. THE PT'S WIFE REPORTED THAT UPON HEARING THE ALARM, SHE REACHED OVER TO TOUCH HER HUSBAND, WHO WAS COLD TO TOUCH. SHE GOT UP, TURNED ON THE LIGHT AND SAW BLOOD ON THE BED AND FLOOR. SHE CALLED 911. SHE STATED SHE CLAMPED THE VENOUS LINE. REPORTEDLY, WHEN SHE CLAMPED THE VENOUS LINE, THE VENOUS FISTULA NEEDLE POPPED OUT. EMS ARRIVED AND STARTED CPR, WHICH WAS STOPPED PER WIFE'S REQUEST. THE POLICED ARRIVED, WHO CALLED THE PT'S PHYSICIAN. THE PT'S WIFE REPORTED THAT THE PT WAS TRANSPORTED TO THE MORTUARY WITH THE ENURESIS DEVICE STILL ON HIS ARM. UPON REVIEW OF THE DIALYSIS TREATMENT RECORD, IT WAS NOTED THAT NUMEROUS DIALYSIS MACHINE ALARMS REQUIRING THE PT RESET THE ALARM BEFORE TREATMENT COULD BE RESUMED OCCURRED THROUGHOUT THE ENTIRE TREATMENT. THE PT'S WIFE REPORTED TO THE HOME THERAPIES STAFF THAT THE VENOUS NEEDLE WAS RE-POSITIONED DURING THE TREATMENT, TIME UNK. PT RECEIVED 8000 UNIT HEPARIN BOLUS UPON INITIATION OF TREATMENT, AND 1000 UNITS/HOUR HEPARIN INFUSION DURING THE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795418 NYTONE BEDWETTING ALARM ENURESIS ALARM KPN NYTONE NY92978

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death