BEUDAMED
    FDA Adverse Event Death Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 14874762 · Received June 30, 2022

    Report

    Report Number
    3003464075-2022-00029
    Event Type
    Death
    Date Received
    June 30, 2022
    Date of Event
    June 7, 2022
    Report Date
    June 30, 2022
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K122051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RECEIVED FOR EVALUATION. ALL PRODUCT MUST MEET ALL QUALITY CRITERIA AND MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. BASED ON THE AVAILABLE INFORMATION, THERE IS NO INDICATION THAT A MALFUNCTION OCCURRED. THE NXSTAGE SYSTEM ONE USER GUIDE STATES THAT A TRAINED AND QUALIFIED PERSON MUST OBSERVE ALL TREATMENTS SO THAT HARMFUL CONDITIONS CAN BE RESPONDED TO PROMPTLY. UDI: (B)(4).

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED ON 08 JUN 2022 FROM THE HOME THERAPY NURSE (HTN) OF A 55-YEAR-OLD MALE PATIENT WITH A MEDICAL HISTORY INCLUDING HYPERTENSION AND END STAGE RENAL DISEASE, STATING THE PATIENT EXPIRED AFTER INITIATION OF A HEMODIALYSIS TREATMENT ON (B)(6) 2022. ADDITIONAL INFORMATION WAS RECEIVED ON 15 JUN 2022 FROM THE HOME THERAPY NURSE (HTN) STATING THAT THE CAREGIVER (CG) CALLED 911 AND EMERGENCY MEDICAL SERVICES PROVIDED CARDIOPULMONARY RESUSCITATION (CPR) ENROUTE TO HOSPITAL. PER THE HTN, THE CAUSE OF DEATH IS ''UNDER INVESTIGATION'' AND NOT AVAILABLE. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2300310 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. NX1000-3

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Death