BEUDAMED
    FDA Adverse Event Death Summary report: Y

    NXSTAGE SYSTEM ONE

    MDR report key: 11649903 · Received April 12, 2021

    Report

    Report Number
    3003464075-2021-00015
    Event Type
    Death
    Date Received
    April 12, 2021
    Date of Event
    March 19, 2021
    Report Date
    April 12, 2021
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K122051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVOLVED DEVICE WAS NOT RECEIVED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED WHICH CONFIRMED THAT THE PRODUCT MET ALL QUALITY CRITERIA AND MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. BASED ON THE AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO INDICATE THAT A MALFUNCTION OCCURRED. A SEARCH OF THE COMPLAINT DATABASE REVEALED NO OTHER SERIOUS EVENTS ASSOCIATED WITH THIS DEVICE. UDI: (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED ON 25 MAR 2021 FROM THE HOME THERAPY MANAGER (HTM) OF A (B)(6) MALE PATIENT WITH A MEDICAL HISTORY OF DIABETES AND END STAGE RENAL DISEASE, STATING THE PATIENT EXPIRED DURING A HEMODIALYSIS TREATMENT ON (B)(6) 2021. ADDITIONAL INFORMATION WAS RECEIVED ON 31 MAR 2021 FROM THE HOME THERAPY NURSE (HTN) STATING THAT THE PATIENT "PULLED OUT HIS NEEDLES ON DIALYSIS" AND THE CAUSE OF DEATH IS EXSANGUINATION. NO OTHER DETAILS OF THE EVENT WERE PROVIDED AND NO INFORMATION WAS RECEIVED TO SUGGEST THE PATIENTS DEATH WAS ATTRIBUTED TO NXSTAGE PRODUCT OR THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547869 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. NX1000-3-A

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Death