BEUDAMED
    FDA Adverse Event Other Summary report: N

    FRESENIUS

    MDR report key: 20017 · Received August 29, 1994

    Report

    Report Number
    20017
    Event Type
    Other
    Date Received
    August 29, 1994
    Date of Event
    March 30, 1994
    Report Date
    May 4, 1994
    Manufacturer
    FRESENIUS USA
    Product Code
    FJI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD NO PROBLEMS PRE DIALYSIS. TEMPERATURE 97.5, PULSE 80, BLOOD PRESSURE 160/100. TWO HOURS IN DIALYSIS. PATIENT COMPLAINED OF CHILLS BLOOD PRESSURE 130/80, TEMPERATURE 98.5 AND INCREASED TO 99.6 WITHIN 5 MINUTES, AT 2.5 HOURS PATIENT CHILSS CONTINUED AND PATIENT REQUESTED TO HAVE DIALYSIS TERMINATED. TYLENOL. UPON DISCHARGE FROM UNIT TEMPERATURE WAS 99.6 AND PATIENT WAS SENT HOME

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRESENIUS HOLLOW FIBER DIALYZER FJI FRESENIUS USA 80 NOT KNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other