BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROSORBA COLUMN

    MDR report key: 183582 · Received August 20, 1998

    Report

    Report Number
    3023288-1998-00002
    Event Type
    Other
    Date Received
    August 20, 1998
    Date of Event
    June 5, 1998
    Report Date
    August 17, 1998
    Manufacturer
    CYPRESS BIOSCIENCE, INC.
    Product Code
    LQQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    13 YEAR OLD FEMALE PT, DIAGNOSIS FOCAL GLOMMERULOSCLEROSIS IN TRANSPLANTED KIDNEY, HAD BEEN RECEIVING COLUMN THERAPY ALTERNATELY WITH PLASMA EXCHANGE. THE TREATMENT ON 7/15/1998 WAS THE PT'S 92ND COLUMN TREATMENT. PRIOR TO THE 90TH COLUMN TREATMENT ON 6/5/1998, THE PT HAD A LARGE LUNCH AND WAS PRE-MEDICATED WITH BENEDRYL BY MOUTH. AFTER APPROXIMATELY 700 ML OF TREATED PLASMA, THE PT PRESENTED FACIAL FLUSHING AND A LARGE EMESIS. THE RETURN OF PLASMA WAS PAUSED FOR 10 MINUTES THEN RESUMED WITHOUT FURTHER INCIDENT. PRIOR TO THE 92ND TREATMENT, THE PT WAS PRE-MEDICATED WITH BENEDRYL BY MOUTH. A SECOND DOSE OF BENDRYL WAS ADMINISTERED TO THE PT 31 MINUTES INTO THE PROCEDURE. AFTER APPROXIMATELY 74 MINUTES (250 TO 300 ML OF RETURNED TREATED PLASMA), THE PT PRESENTED CHEST TIGHTNESS AND SLIGHTLY CYANOTIC LIPS. NO WHEEZING WAS EVIDENT AND THE PT REFUSED OXYGEN. THE PT'S CONDITION RESOLVED ITSELF WITHIN 10 MINUTES AFTER TREATMENT ABORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSORBA COLUMN PROTEIN A IMMUNOADSORPTION COLUMN LQQ CYPRESS BIOSCIENCE, INC. NA 122297A, 042998F

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Other