BEUDAMED
    FDA Adverse Event Death Summary report: N

    NXSTAGE

    MDR report key: 4328466 · Received November 4, 2014

    Report

    Report Number
    4328466
    Event Type
    Death
    Date Received
    November 4, 2014
    Date of Event
    October 29, 2014
    Report Date
    November 4, 2014
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CLINIC STAFF RECEIVED A PHONE CALL FROM PT'S WIFE WHILE PT WAS RECEIVING HIS HOME HEMODIALYSIS TREATMENT. WIFE STATED SHE WAS IN TROUBLE AND THAT "HE WENT OUT ON HER." WIFE REPORTED PT WAS NOT RESPONDING. SHE STATED SHE WAS UNABLE TO CALL 911 SO THE CLINIC STAFF CALLED 911. THE 911 EMS WAS SENT TO THE HOUSE AND IT WAS REPORTED THAT THE PT WAS PRONOUNCED DEAD UPON EMS ARRIVAL TO THE HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705998 NXSTAGE HIGH FLUX SYSTEM ONE DIALYSIS MACHINE KDI NXSTAGE MEDICAL, INC. CYC-DTE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death NORMAL SALINE| CAR171B| SAK 404