BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSORBA COLUMN

    MDR report key: 589691 · Received April 7, 2005

    Report

    Report Number
    3032792-2005-00007
    Event Type
    Injury
    Date Received
    April 7, 2005
    Date of Event
    March 10, 2005
    Manufacturer
    FRESENIUS HEMOCARE
    Product Code
    LQQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT ADMITTED TO HOSP AFTER THEIR THIRD PROSORBA TREATMENT WITH FEVER, CHILLS AND HIGH WBC. DIAGNOSED WITH UTI AND ACUTE RENAL FAILURE PROBABLY SECONDARY TO VASCULITIS. PT HAD A HISTORY OF RACH ON THEIR LOWER EXTEMITIES THAT BEGAN AFTER THEIR FIRST PROSORBA TREATMENT. PT WAS TREATED WITH HIGH DOSE STEROIDS, ANTIBIOTICS, HYDRATION AND LOW DOSE DOPAMINE FOR RENAL PERFUSION. THEIR RENAL AND RASH SYMPTOMS RESOLVED AND PT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSORBA COLUMN PROSORBA COLUMN LQQ FRESENIUS HEMOCARE 9798701 QHN001D

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization PREDNISONE, PRILOSEC, VICODIN, ARIMEDEX, FOSAMAX,| ASPIRIN.