BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDICAL COMPONENTS, INC

    MDR report key: 1237830 · Received November 18, 2008

    Report

    Report Number
    1237830
    Event Type
    Death
    Date Received
    November 18, 2008
    Date of Event
    November 10, 2008
    Report Date
    November 14, 2008
    Manufacturer
    MEDICAL COMPONENTS, INC
    Product Code
    MSD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED HEMODIALYSIS. MACHINE ALARMED. PT FOUND BRADYCARDIC THEN BECAME UNRESPONSIVE. BLOOD NOTED ON FLOOR. CODE BLUE CALLED. PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDICAL COMPONENTS, INC DUAL LUMEN HEMODIALYSIS CATHETER MSD MEDICAL COMPONENTS, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death GAMBRO HEMODIALYSIS MACHINE AND TUBING