BEUDAMED
    FDA Adverse Event Death Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 3972903 · Received July 7, 2014

    Report

    Report Number
    3003464075-2014-00015
    Event Type
    Death
    Date Received
    July 7, 2014
    Date of Event
    May 10, 2014
    Report Date
    June 2, 2014
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. A REVIEW OF THE REPORTED LOT NUMBER FOUND NO OTHER COMPLAINTS IN THE AGILE COMPLAINT DATABASE. THE INSTRUCTIONS FOR USE CONTAIN ADEQUATE WARNINGS TO USE ONLY AFTER OPENING THE PEEL SEAM AND MIXING THE TWO SOLUTIONS AND THAT APPROPRIATE MONITORING OF PT'S HEMODYNAMIC, FLUID, ELECTROLYTE AND ACID-BASE BALANCE SHOULD BE PERFORMED. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFORMATION WILL BE PROVIDED.

    Description of Event or Problem · 1

    ON (B)(6) 2014 AT APPROXIMATELY 8:20 AM FRESENIUS NURSE WAS NOTIFIED THAT PT (B)(6) HAD DIED WHILE RECEIVING CRRT TREATMENT. TREATMENT HAD COMMENCED (B)(6) AT APPROXIMATELY 5:35 PM, 3 BAGS OF DIALYSATE WERE HUNG BY FRESENIUS NURSE AT START OF TREATMENT. THREE MORE BAGS OF DIALYSATE WERE HUNG BY ICU NURSE MONITORING PT DURING THE NIGHT. WHEN FRESENIUS NURSE WENT TO DISASSEMBLE NXTSTAGE MACHINE SHE NOTED THAT ALL THREE DIALYSATE BAGS HANGING HAD NOT HAD INTERIOR SEALS BROKEN FOR THE CONTENTS TO MIX. PT WAS DIALYZED WITH UNMIXED DIALYSATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394699 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYS KDI NXSTAGE MEDICAL, INC. RFP-401 F044813

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death