BEUDAMED
    FDA Adverse Event Death Summary report: N

    NXSTAGE MEDICAL

    MDR report key: 559785 · Received December 8, 2004

    Report

    Report Number
    559785
    Event Type
    Death
    Date Received
    December 8, 2004
    Date of Event
    December 8, 2004
    Report Date
    December 8, 2004
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    FKJ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    A PATIENT WITH MULTIPLE MEDICAL PROBLEMS WAS TRANSFERRED FROM AN OUTSIDE HOSPITAL STATUS POST MYOCARDIAL INFARCTION AND PTCA, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY, STENT PLACEMENT. THE PATIENT WAS ON BEDSIDE HEMODIALYSIS IN THE ICU. IT WAS NOTED THAT THE FILTER WAS LEAKING APPROXIMATELY 300 TO 400 CC OF BLOOD ONTO THE FLOOR. THE PATIENT WENT INTO VENTRICULAR TACHYCARDIA AND A CODE WAS CALLED. RESUSCITATION WAS UNSUCCESSFUL AND THE PATIENT EXPIRED. CURRENTLY INVESTIGATING CAUSE OF LEAK WITH INDEPENDENT EVALUATION. RESULTS OF THE INVESTIGATION ARE PENDING.FOLLOW UP WITH THE SITE REVEALS THAT THE FILTER IS AN INTEGRAL PART OF THE SINGLE USE 'CARTRIDGE' USED WITH THE NXSTAGE SYSTEM ONE PORTABLE DIALYSIS UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NXSTAGE MEDICAL HEMODIALYSIS FILTER FKJ NXSTAGE MEDICAL, INC. * FG 041 1109
    2 SYSTEM ONE DIALYSIS UNIT KDI NXSTAGE MEDICAL, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death