BEUDAMED
    FDA Adverse Event Other Summary report: N

    FRESENIUS

    MDR report key: 17505 · Received August 11, 1994

    Report

    Report Number
    17505
    Event Type
    Other
    Date Received
    August 11, 1994
    Date of Event
    May 4, 1994
    Report Date
    May 12, 1994
    Manufacturer
    FRESENIUS USA
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS PATIENT OFFERED NO COMPLAINTS PRE TREATMENT. 95 MINUTES INTO THE TREATMENT SHE C/O CHILLS AND STARTED SHIVER. DR. NOTIFIED. BLOOD CULTURES PYROGEN TESTING + CBC ORDERED. THE TREATMENT WAS DISCONTINUED AND SHE WAS RESTARTED ON A PRE PROCESSED F80. SHE WAS GIVEN 1 GM VANCO AND 80 MG GENTAMYCIN. SHE COMPLETED HER FULL TREATMENT AND WAS SENT HOME. PRE TEMP 98.6 F MAX - 100.5 POST 98.6NO 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 FRESENIUS USA F80/F80 A (HF/PS/1.8 H) NOT AVAILABLE

    Patients

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