BEUDAMED
    FDA Adverse Event Death Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 5238771 · Received November 20, 2015

    Report

    Report Number
    3003464075-2015-00027
    Event Type
    Death
    Date Received
    November 20, 2015
    Date of Event
    October 20, 2015
    Report Date
    October 28, 2015
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE CYCLER IS PENDING RETURN AT THE TIME OF THIS REPORT, THEREFORE EVALUATION IS ONGOING. CAR-170C LOT # 50777013 AND SAK-307 LOT # 50279017 WERE RETURNED AND NO PROBLEMS WERE IDENTIFIED UPON EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE (B)(6) REPORTED THAT ON (B)(6) 2015 A (B)(6) FEMALE PATIENT EXPIRED DURING MANUAL RINSEBACK. APPROXIMATELY 3 MINUTES INTO TREATMENT A SYSTEM ALARM HAD OCCURRED. THE PATIENT AND CAREGIVER ELECTED TO END THERAPY AND PERFORM A MANUAL RINSEBACK. DURING MANUAL RINSEBACK, THE PATIENT BECAME NAUSEATED, GLASSY EYED. A 911 WAS CALLED. THE PATIENT WAS IN VENTRICULAR FIBRILLATION WHEN THE PARAMEDICS ARRIVED. CPR WAS INITIATED. THE PATIENT WAS PRONOUNCED DECEASED AT THE EMERGENCY ROOM 20 MINUTES LATER. THE CAUSE OF DEATH WAS DOCUMENTED AS CARDIAC ARREST. NO AUTOPSY WAS PERFORMED. A RELATIONSHIP TO THE THERAPY COULD NOT BE EXCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768569 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. NX1000-1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death