BEUDAMED
    FDA Adverse Event Death Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 14427490 · Received May 18, 2022

    Report

    Report Number
    3003464075-2022-00018
    Event Type
    Death
    Date Received
    May 18, 2022
    Date of Event
    March 6, 2022
    Report Date
    May 17, 2022
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVOLVED CYCLER WAS NOT RECEIVED FOR EVALUATION. 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 THAT TREATMENT SHOULD ONLY BE PERFORMED BY A TRAINED AND QUALIFIED PERSON WHO MUST RESPOND PROMPTLY TO HARMFUL CONDITIONS DURING TREATMENT. UDI: (B)(4).

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED ON 07 MAR 2022 FROM THE HOME THERAPY NURSE (HTN) OF A (B)(6) MALE PATIENT WITH A MEDICAL HISTORY INCLUDING DIABETES AND END STAGE RENAL DISEASE, WHO STATED THE PATIENT PASSED AWAY FOLLOWING A HOME HEMODIALYSIS TREATMENT ON (B)(6) 2022. ADDITIONAL INFORMATION WAS RECEIVED ON 22 APR 2022 FROM THE ACCOUNT MANAGER WHO STATED 2.5 HOURS INTO TREATMENT THE PATIENT EXPERIENCED A CARDIAC EVENT, WAS REVIVED, AND PASSED AWAY THE FOLLOWING DAY IN THE HOSPITAL. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION REGARDING DETAILS OF THE EVENT AND HOSPITALIZATION WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1851153 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. NX1000-1

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Death| H