BEUDAMED
    FDA Adverse Event Death Summary report: N

    FMC COMBISET BLOOD LINES

    MDR report key: 383003 · Received February 27, 2002

    Report

    Report Number
    383003
    Event Type
    Death
    Date Received
    February 27, 2002
    Date of Event
    January 30, 2002
    Report Date
    February 25, 2002
    Manufacturer
    FMC
    Product Code
    FJK
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MACHINE AIR DETECTOR ALARM SOUNDED WITH NOTED BUBBLES IN THE ARTERIAL BLOODLINE FROM THE PT TO POST PUMP CHAMBER AND VENOUS CHAMBER. PT COMPLAINED OF NOT FEELING WELL AND BECAME UNRESPONSIVE. PLACED IN TRENDELENBURG ON LEFT SIDE. CPR INITIATED. EMS ACTIVATED AND PT TRANSFERRED TO HOSPITAL. PT EXPIRED AT HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FMC COMBISET BLOOD LINES DIALYSIS ARTERIAL/VENOUS BLOODLINES FJK FMC 03-2632-2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Death DIALYSIS.| FMC COMBISET BLOODLINES, BAXTER 1550 MACHINE FOR