BEUDAMED
    FDA Adverse Event Other Summary report: N

    FRESENIUS

    MDR report key: 19304 · Received June 7, 1994

    Report

    Report Number
    2243621-1994-05137
    Event Type
    Other
    Date Received
    June 7, 1994
    Date of Event
    May 4, 1994
    Report Date
    May 24, 1994
    Manufacturer
    FRESENIUS USA
    Product Code
    FJI
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS PT OFFERED NO COMPLAINTS PRE TREATMENT. 95 MINUTES INTO THE TREATMENT SHE COMPLAINED OF CHILLS AND STARTED TO SHIVER. DR. NOTIFIED. BLOOD CULTURES, PYROGEN TESTING AND CBC ORDERED. THE TREATMENTMENT WAS DISCONTINUEDAND SHE WAS RESTARTED ON A PREPROCESSED F-80. SHE WAS GIVEN 1 GM VANCO AND 80MG DGENTAMYCIN. SHE COMPLETED HER FULL TREATMENT AND WAS SENT HOME. PRE TEMP 98.6 MAX 100.5 POST 98.6.NO DEFINITIVE REASON COULD BE FOUND FOR THIS EVENT, THEREFORE THIS MDR IS BEING FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRESENIUS HOLLOW FIBER HIGH FLUX HEMODIALYZER FJI FRESENIUS USA F80/F80A(HF/PS/1.8H) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other FRESENIUS 2008 E DIALYSIS MAACCHINE