BEUDAMED
    FDA Adverse Event Death Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 20248509 · Received September 18, 2024

    Report

    Report Number
    3003464075-2024-00259
    Event Type
    Death
    Date Received
    September 18, 2024
    Date of Event
    August 23, 2024
    Report Date
    September 18, 2024
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CYCLER WAS NOT RECEIVED FOR EVALUATION AND NO DEFECT WAS FOUND DURING EVALUATION OF THE INVOLVED CARTRIDGE. 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. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION FROM THE AVAILABLE INFORMATION. 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 23 AUG 2024 FROM THE HOME THERAPY NURSE (HTN) OF PATIENT (B)(6), A 49 YEAR OLD FEMALE WITH A MEDICAL HISTORY INCLUDING MULTIPLE COMORBIDITIES AND END STAGE RENAL DISEASE APPROVED FOR PERFORMING SOLO HOME HEMODIALYSIS THERAPY, WHO STATED THE PATIENT WAS FOUND WITH THE ARTERIAL LINE DISCONNECTED AND AN UNSPECIFIED AMOUNT OF BLOOD LOST DURING A HOME HEMODIALYSIS TREATMENT ON (B)(6) 2024. ADDITIONAL INFORMATION WAS RECEIVED ON 27 AUG 2024 FROM THE HTN STATING THE PATIENT WAS FOUND UNRESPONSIVE WITH THE CENTRAL VENOUS CATHETER LEAKING. UPON EMERGENCY MEDICAL SERVICES (EMS) ARRIVAL THE PATIENT WAS BRADYCARDIC (NOS) WITH LOW BLOOD PRESSURE (NOS), FLUIDS (NOS) WERE ADMINISTERED. THE PATIENT WAS TRANSPORTED TO THE EMERGENCY ROOM (ER) AND CODED APPROXIMATELY 15 MINUTES UPON ARRIVAL. THE PATIENT WAS REVIVED BUT EXPIRED THE FOLLOWING MORNING, CAUSE OF DEATH HEART ATTACK/BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1318226 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. NX1000-1

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Death| H| R