BEUDAMED
    FDA Adverse Event Death Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 3911492 · Received May 28, 2014

    Report

    Report Number
    3003464075-2014-00009
    Event Type
    Death
    Date Received
    May 28, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO EVIDENCE TO SUGGEST A MALFUNCTION OF THE DEVICE CONTRIBUTED TO THE AIR EMBOLISM. ANALYSIS OF THE PT TREATMENT LOG FILES FOR THIS EVENT SHOWS THAT AFTER THE SUCCESSFUL PRIME AND ALARMS TESTING, THE PT HAD INADVERTENTLY MADE ALL TREATMENT CONNECTIONS WHILE STILL IN THE RECIRCULATION PHASE OF THE PRIME AND ALARMS TEST. TWO ALARMS OCCURRED AT THIS TIME WHICH SHOULD HAVE ALERTED THE PT. THE LOG FILE CONFIRMS THE PT'S CAUSE OF DEATH IDENTIFIED FROM THE AUTOPSY AS WELL AS THE NURSE'S OBSERVATION OF THE CYCLER STILL IN THE PRIME AND ALARMS PHASE. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADD'L INFO WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE HOME TRAINING NURSE REPORTED THAT THE PT EXPIRED DURING A ROUTINE HEMODIALYSIS TREATMENT. THE NSO CYCLER WAS DISPLAYING STEP 23 OF THE PRIME AND ALARMS TEST WHEN FOUND. THE PT'S MEDICAL HISTORY INCLUDES LOW BP, PREVIOUS HEART ATTACK AND HEART SURGERY. AN AUTOPSY WAS PERFORMED WITH THE CAUSE OF DEATH LISTED AS AIR EMBOLISM, ACCIDENTAL DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313547 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTE KDI NXSTAGE MEDICAL, INC. CAR-170-C 40177023

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death