BEUDAMED
    FDA Adverse Event Death Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 12631529 · Received October 14, 2021

    Report

    Report Number
    3003464075-2021-00052
    Event Type
    Death
    Date Received
    October 14, 2021
    Date of Event
    September 22, 2021
    Report Date
    October 14, 2021
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K170469
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO DEVICE MALFUNCTION. THE DEVICE WAS RECEIVED FOR EVALUATION AND SUCCESSFULLY PASSED TESTING. AVAILABLE LOG FILES WERE RETRIEVED AND ANALYZED WHICH SHOWED THE CYCLER PERFORMED AS INTENDED AND ALARMED APPROPRIATELY WHEN THE ALARM CONDITIONS WERE PRESENT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED WHICH CONFIRMED THAT THE DEVICE MET ALL QUALITY CRITERIA AND MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. UDI: (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED ON (B)(6) 2021 FROM THE HOME THERAPY NURSE (HTN) OF A (B)(6) MALE WITH A MEDICAL HISTORY INCLUDING DIABETES AND END STAGE RENAL DISEASE, WHO STATED THE PATIENT EXPERIENCED A CARDIAC EVENT AT THE CONCLUSION OF A HOME HEMODIALYSIS TREATMENT ON (B)(6) 2021. ADDITIONAL INFORMATION WAS RECEIVED ON 23 SEP 2021 FROM THE HTN WHO STATED THE PATIENT COMPLAINED OF CHEST PAIN AND PASSED OUT IMMEDIATELY AT THE END OF TREATMENT, AFTER RINSEBACK WAS PERFORMED. PER THE HTN, PATIENT EXPIRED AT AN UNSPECIFIED TIME SAME DAY, CAUSE OF DEATH WAS CARDIAC ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1534543 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. NX1000-16-A

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Death