BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSORBA COLUMN

    MDR report key: 480184 · Received August 19, 2003

    Report

    Report Number
    3032792-2003-00003
    Event Type
    Injury
    Date Received
    August 19, 2003
    Date of Event
    July 17, 2003
    Report Date
    August 18, 2003
    Manufacturer
    FRESENIUS HEMOCARE, INC.
    Product Code
    LQQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WENT TO ER WITH SLURRED SPEECH, LOW BLOOD PRESSURE AND ALTERED GAIT THE EVENING AFTER THEIR FIRST PROSOBA COLUMN TREATMENT. RHEUMATOLOGIST FEELS PT HAD SOME KIND OF CEREBROVASCULAR EVENT AND THAT PT MAY HAVE HAD SOME EXISTING DISEASE THAT WAS EXACERBATED BY HYPOTENSION/HYPOVOLEMIA DURING THE PROSORBA COLUMN PROCEDURE. CO HAS BEEN UNABLE TO OBTAIN RECORDS TO CONFIRM WHETHER THE PT WAS ADMITTED AND WHAT DIAGNOSTIC TESTS WERE RUN. CO WAS INFORMED PT STILL HAS SOME RESIDUAL SLURRED SPEECH. PHYSICIAN IS TRYING TO OBTAIN RECORDS FROM THE HOSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSORBA COLUMN PROSOBRA COLUMN LQQ FRESENIUS HEMOCARE, INC. 9798701 PCN001A

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization SERAVENT| HCTZ| FLONASE| NIFEDIPINE| BEXTRA| PREDNISONE