BEUDAMED
    FDA Adverse Event Death Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 12518275 · Received September 23, 2021

    Report

    Report Number
    3003464075-2021-00044
    Event Type
    Death
    Date Received
    September 23, 2021
    Date of Event
    September 4, 2021
    Report Date
    September 23, 2021
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO DEVICE MALFUNCTION. THE DEVICE WAS RECEIVED FOR EVALUATION AND SUCCESSFULLY PASSED TESTING. AVAILABLE LOG FILES WERE RETRIEVED AND ANALYZED WHICH SHOWED THE DEVICE WAS PERFORMING AS DESIGNED AND INTENDED. 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. (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED ON (B)(6) 2021 FROM THE FAMILY MEMBER OF A (B)(6) FEMALE WITH A MEDICAL HISTORY INCLUDING END STAGE RENAL DISEASE, WHO STATED THE PATIENT FELT DIZZY AND PASSED OUT AT THE END OF A HOME HEMODIALYSIS TREATMENT ON (B)(6) 2021. 911 WAS CALLED AND THE PATIENT WAS TRANSPORTED TO THE HOSPITAL WHERE THEY LATER PASSED AWAY. ADDITIONAL INFORMATION WAS RECEIVED ON 08 SEP 2021 FROM THE HOME THERAPY NURSE (HTN) WHO STATED WITH 12 MINUTES REMAINING ON TREATMENT THE PATIENT FELT DIZZY AND BECAME UNRESPONSIVE. THE PATIENTS CAREGIVER ADMINISTERED SALINE, CALLED 911, THEN PROCEEDED TO GIVE MOUTH TO MOUTH UNTIL PARAMEDICS ARRIVED. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL AND PRONOUNCED AT AN UNSPECIFIED TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1417088 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. NX1000-1

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death