BEUDAMED
    FDA Adverse Event Death Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 3826864 · Received May 2, 2014

    Report

    Report Number
    3003464075-2014-00008
    Event Type
    Death
    Date Received
    May 2, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 4, 2014
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO EVIDENCE TO SUGGEST THE NSA EQUIPMENT OR TREATMENT CONTRIBUTED TO THE PT'S ELEVATED POTASSIUM. NO PROBLEMS WERE FOUND DURING ON SITE EVALUATION OF THE NSO CYCLER. THE DISPOSABLE CARTRIDGE WAS RETURNED FOR EVALUATION WITH NO PROBLEMS FOUND. REVIEW OF THE PT TREATMENT LOG FILES FOR THIS EVENT INDICATES THERE IS NO EVIDENCE TO SUGGEST A PROBLEM WITH THE SYSTEM WHICH WOULD RESULT IN ELEVATED POTASSIUM LEVELS. IN ADDITION, THERE IS NO EVIDENCE OF HEMOLYSIS GENERATED BY THE SYSTEM. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFO WILL BE PROVIDED.

    Description of Event or Problem · 1

    AN UNSPECIFIED PATIENT WITH COMORBIDITIES AND ON A VENTILATOR WAS STARTED ON CRRT ON (B)(6) 2014. AFTER APPROX 8 HOURS, 42 MINUTES THE PT'S POTASSIUM LEVEL INCREASED FROM 4-8. RINSEBACK WAS PERFORMED AND TREATMENT DISCONTINUED. BP REPORTED AS NORMAL ONCE CRRT STOPPED. APPROXIMATELY 2 HOURS AFTER CRRT WAS DISCONTINUED, THE PT DEVELOPED AN ABNORMAL EKG AND 30 MINUTES LATER CODED. APPROXIMATELY 47 MINUTES LATER, THREE HOURS AFTER CRRT WAS DISCONTINUED, THE PATIENT DIED. FOLLOW UP WITH THE NURSE CONFIRMED THE PATIENT WAS NOT ON VASOPRESSORS. NO ADDITIONAL INFO IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264876 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. CAR-500 30978005

    Patients

    Seq Age Sex Outcome Treatment
    1 Death