BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 9347323 · Received November 20, 2019

    Report

    Report Number
    3003464075-2019-00060
    Event Type
    Injury
    Date Received
    November 20, 2019
    Date of Event
    October 24, 2019
    Report Date
    November 20, 2019
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVOLVED CYCLER WAS NOT RECEIVED FOR EVALUATION. THE CYCLER SERIAL NUMBER WAS NOT PROVIDED. WITHOUT A SERIAL NUMBER, A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS UNABLE TO BE PERFORMED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED ON (B)(6) 2019 FROM THE HOME THERAPY NURSE (HTN) OF A (B)(6) YEAR OLD MALE WITH A MEDICAL HISTORY OF TYPE II DIABETES WITH OTHER DIABETIC KIDNEY COMPLICATIONS (NOS), IRON ANEMIA IN CHRONIC KIDNEY DISEASE (CKD), IRON DEFICIENCY ANEMIA, HYPERTENSIVE CKD WITH STAGE 5 CKD, AND SECONDARY HYPERPARATHYROIDISM OF RENAL ORIGIN, STATING THE PATIENT WAS ADMITTED TO HOSPITAL ON (B)(6) 2019 WITH VOLUME OVERLOAD AND ELEVATED CARDIAC ENZYMES. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2019 FROM THE HTN STATING THE PATIENT REMAINS HOSPITALIZED AT THIS TIME. PER THE HTN, THERE IS NO INDICATION OF A DEVICE MALFUNCTION AND THE PHYSICIAN STATED THE PATIENT REQUIRED REASSESSMENT OF THEIR DRY WEIGHT. ALTHOUGH REQUESTED, NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1143768 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. NX1000-1

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization