BEUDAMED
    FDA Adverse Event Other Summary report: N

    FRESENIUS

    MDR report key: 19514 · Received August 11, 1994

    Report

    Report Number
    19514
    Event Type
    Other
    Date Received
    August 11, 1994
    Date of Event
    March 23, 1994
    Report Date
    April 7, 1994
    Manufacturer
    UNKNOWN
    Product Code
    KOC
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PRE TX PT DENIED ANY COMPLIANTS, ONE HOUR INTO TX, PT C/O CHILLS TEMP UP TO 101.6 (FROM 99 DEGREE) PHYSICIAN WAS NOTIFIED, VANOMYCIN & GINTAMYCIN GIVEN IV. PT TAKEN OFFF THIS DIALYZER AND PLACED ON A NEW ONE. SYMPTOMS INPROVED, POST TEMP 99.3 DEGREE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRESENIUS HEMODIALYZER KOC UNKNOWN F-80 DIB231

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other BLOOD LINES BY FRESENIUS