BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSORBA COLUMN

    MDR report key: 81958 · Received April 2, 1997

    Report

    Report Number
    3023288-1997-00002
    Event Type
    Injury
    Date Received
    April 2, 1997
    Date of Event
    March 3, 1997
    Report Date
    April 1, 1997
    Manufacturer
    CYPRESS BIOSCIENCE, INC. (FORMERLY IMRE CORP)
    Product Code
    LQQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WITH A DIAGNOSIS OF HEMOLYIC UREMIC SYNDROME (HUS) WAS TREATED WITH HIS FIRST COLUM TREATMENT ON 3/30/97. APPROX 35 MINS INTO PROCEDURE PT COMPLAINED OF FEELING NAUSEOUS. AT THIS TIME IT WAS NOTED THAT HIS BLOOD PRESSURE WAS 78.47 AND HE WAS VERY PALE. HE VOMITED A LARGE AMOUNT AND THEN LOST CONSCIOUSNESS. PROCEDURE WAS PUT IN A TRENDELENBERG'S POSITION. ACCORDING TO NURSE, PT BECAME RESPONSIVE 2 OR 3 MINUTES LATER. PHYSICIAN WAS CALLED AND HE ORDERED THE PROCEDURE DISCONTINUED AND 500CC HISPAN WAS GIVEN TO PT. PT HAD BEEN PREMEDICATED WITH BENEDRYL AND TYLENOL BEFORE TREATMENT WITH COLUMN. ONE HOUR POST-TREATMENT DISCONTINUATION. PT'S VITAL SIGNS WERE NORMAL. PT WAS KEPT IN HOSP OVERNIGHT AND DISCHARGED NEXT DAY. PT HAS BEEN ON AN ANGIOTENSIN CONVERTING ENZYME (ACE) INHIBITOR MEDICATION LOTENSION, WHICH HAD BEEN DISCONTINUED ON 2/27/97. USE OF COLUMN IS CONTRADICTED IN PTS RECEIVING ACE INHIBITOR MEDICATIONS. PT WAS READMITTED ON 3/35/97 WITH CELLUTIS ON HIS RIGHT ARM, RIGHT UPPER EPIGASTRIC PAIN AND SWELLING WITH TRACE EDEMA, AND RIGHT UPPER SHOULDER PAIN. ON 3/6/97 PT UNDEWENT PLASMA EXCHANGE WITH FRESH-FROXEN PLASMA AND CELLUITIS HAD RESOLVED BY THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSORBA COLUMN PROTEIN A IMMUNOADSORPTION COLUM LQQ CYPRESS BIOSCIENCE, INC. (FORMERLY IMRE CORP) NA 011897J

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization