BEUDAMED
    FDA Adverse Event Death Summary report: Y

    NXSTAGE SYSTEM ONE

    MDR report key: 11826482 · Received May 14, 2021

    Report

    Report Number
    3003464075-2021-00024
    Event Type
    Death
    Date Received
    May 14, 2021
    Date of Event
    April 16, 2021
    Report Date
    May 14, 2021
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K122051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    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 · 1

    A REPORT WAS RECEIVED ON 26 APR 2021 FROM THE HOME THERAPY NURSE (HTN) OF A (B)(6) YEAR OLD MALE WITH A MEDICAL HISTORY INCLUDING CONGESTIVE HEART FAILURE, ABDOMINAL AORTIC ANEURYSM, 90% BLOCKAGE IN CAROTID ARTERY, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, HYPERTENSION AND END STAGE RENAL DISEASE, STATING THE PATIENT WAS FOUND EXPIRED AT AN UNSPECIFIED TIME WHILE PERFORMING A STANDARD HEMODIALYSIS TREATMENT WITHOUT A CARE PARTNER PRESENT ON (B)(6) 2021. ADDITIONAL INFORMATION WAS RECEIVED ON 27-28 APR 2021 FROM THE HTN WHO STATED THE RECORD FOR THE DATE OF THE EVENT SHOWED TREATMENT WAS UNREMARKABLE AND MET THE PROGRAMED PARAMETERS FOR THE THERAPY SESSION. THE CAREGIVER ENTERED THE ROOM AND FOUND THE PATIENT UNRESPONSIVE AND CONNECTED TO THE DEVICE. EMERGENCY MEDICAL SERVICES (EMS) WERE CALLED AND THE PATIENT WAS PRONOUNCED. PER THE HTN, THE CAUSE OF DEATH IS LIKELY RELATED TO THE PATIENT'S EXTENSIVE CARDIAC COMORBIDITIES, UNRELATED TO NXSTAGE PRODUCT AND THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720941 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. NX1000-3

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death