BEUDAMED
    FDA Adverse Event Death Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 20871311 · Received December 6, 2024

    Report

    Report Number
    3003464075-2024-00275
    Event Type
    Death
    Date Received
    December 6, 2024
    Date of Event
    November 12, 2024
    Report Date
    December 6, 2024
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K170469
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO DEVICE MALFUNCTION. THE CYCLER WAS RECEIVED FOR EVALUATION AND SUCCESSFULLY PASSED TESTING. EVALUATIONS OF THE INVOLVED LOG FILES, CARTRIDGE AND DIALYSATE SAK WERE UNREMARKABLE WITH NO DEVICE PROBLEM FOUND. 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. THE NXSTAGE SYSTEM ONE USER GUIDE SUPPLEMENT FOR SOLO HOME HEMODIALYSIS OUTLINES RISKS, WARNINGS, AND REQUIREMENTS FOR THE SOLO HOME HEMODIALYSIS PATIENT. UDI: (B)(4).

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED ON (B)(6) 2024 FROM THE HOME THERAPY NURSE (HTN) OF A 63 YEAR OLD MALE PATIENT APPROVED FOR PERFORMING SOLO HEMODIALYSIS WITH A MEDICAL HISTORY INCLUDING END STAGE RENAL DISEASE, WHO STATED THE PATIENT EXPIRED DURING A HOME HEMODIALYSIS TREATMENT ON (B)(6) 2024. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2024 FROM THE HOME THERAPY NURSE (HTN) WHO STATED THE PATIENT WAS FOUND UNRESPONSIVE AND STILL CONNECTED TO THE MACHINE, SURROUNDED BY AN UNSPECIFIED AMOUNT OF BLOOD. PER THE NEPHROLOGIST THE SUSPECTED CAUSE OF DEATH WAS CARDIAC EVENT, WITH SECONDARY POSSIBLE HEMORRHAGIC SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2094295 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. NX1000-16

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Death