BEUDAMED
    FDA Adverse Event Death Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 20102336 · Received August 29, 2024

    Report

    Report Number
    3003464075-2024-00252
    Event Type
    Death
    Date Received
    August 29, 2024
    Date of Event
    August 4, 2024
    Report Date
    August 29, 2024
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K122051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CYCLER WAS NOT RECEIVED FOR EVALUATION. 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. THE NXSTAGE SYSTEM ONE USER GUIDE OUTLINES RISKS ASSOCIATED WITH PERFORMING HEMODIALYSIS THERAPY AND WARNS ALL TREATMENTS MUST BE ADMINISTERED UNDER A PHYSICIAN'S PRESCRIPTION AND MUST BE PERFORMED BY A TRAINED AND QUALIFIED PERSON, CONSIDERED TO BE COMPETENT IN THE USE OF THIS DEVICE BY THE PRESCRIBING PHYSICIAN. UDI: (B)(4).

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED ON (B)(6) 2024 FROM A HOME THERAPY NURSE (HTN) REGARDING A 55-YEAR-OLD MALE PATIENT WITH A MEDICAL HISTORY INCLUDING DIABETES AND END STAGE RENAL DISEASE, WHO STATED THE PATIENT EXPIRED DURING A HOME HEMODIALYSIS TREATMENT ON (B)(6) 2024. ADDITIONAL INFORMATION WAS RECEIVED ON 07 AUG 2024 FROM THE HOME THERAPY NURSE (HTN) WHO STATED THE PATIENT STOOD UP AFTER APPROXIMATELY THREE HOURS INTO THERAPY AND COLLAPSED WITH NO VERBAL COMMENT, DISLODGING HIS CENTRAL VENOUS CATHETER. PER THE HTN, A PULSE WAS PALPABLE, AND EMERGENCY SERVICES (EMS) WERE CALLED, WITH THE PATIENT EXPIRING BY THE TIME EMS ARRIVED. ALTHOUGH REQUESTED, NO CAUSE OF DEATH WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1794755 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. NX1000-3

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Death