BEUDAMED
    FDA Adverse Event Death Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 12860497 · Received November 23, 2021

    Report

    Report Number
    3003464075-2021-00067
    Event Type
    Death
    Date Received
    November 23, 2021
    Report Date
    November 23, 2021
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K133547
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE SERIAL NUMBER WAS PROVIDED AND NO PRODUCT WAS 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.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED ON (B)(6) 2021 FROM THE NEPHROLOGIST OF A CRITICAL CARE PATIENT WITH AN UNSPECIFIED PATHOLOGY, WHO STATED THAT THE PATIENT EXPIRED AND WAS FOUND TO HAVE ¿AIR IN CEREBRUM¿ FOLLOWING A CRITICAL CARE ADMISSION INCLUDING CONTINUOUS RENAL REPLACEMENT THERAPY ON AN UNSPECIFIED DATE. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1756494 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. NX1000-5

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death