BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSORBA COLUMN

    MDR report key: 367176 · Received December 17, 2001

    Report

    Report Number
    3032792-2001-00035
    Event Type
    Injury
    Date Received
    December 17, 2001
    Date of Event
    November 14, 2001
    Report Date
    December 17, 2001
    Manufacturer
    FRESENIUS HEMOCARE, INC.
    Product Code
    LQQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS TREATED FOR CENTRAL VENOUS CATHETER INFECTION AFTER THEIR THIRD COLUMN TREATMENT. WHEN CATHETER WAS REMOVED AFTER THE 12TH TREATMENT PATIENT DEVELOPED AN INFECTED FISTULA AT THE CATHETER SITE PATIENT WAS HOSPITALIZED APPROXIMATELY 2 WEEKS LATER FOR 5 DAYS WITH DX OF PNEUMONIA. TWO WEEKS LATER AND 5 WEEKS AFTER THE LAST COLUMN TREATMENT PATIENT WAS AGAIN HOSPITALIZED AND WAS DIAGNOSED WITH A DEEP VEIN THROMBOSIS AND PULMONARY EMBOLI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57126 PROSORBA COLUMN IMMUNOADSORPTION COLUMN LQQ FRESENIUS HEMOCARE, INC. 9798701 051501E

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization