BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSORBA COLUMN

    MDR report key: 296494 · Received September 14, 2000

    Report

    Report Number
    3023288-2000-00009
    Event Type
    Injury
    Date Received
    September 14, 2000
    Date of Event
    August 14, 2000
    Report Date
    September 14, 2000
    Manufacturer
    CYPRESS BIOSCIENCE, INC.
    Product Code
    LQQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PT WITH SEVERE "RA" COMPLETED 7 PROSORBA COLUMN TREATMENTS. PT HAD EXPERIENCED CHEST DISCOMFORT EARLIER IN THE WEEK PRIOR TO THEIR 7TH PROSORBA TREATMENT, BUT SYMPTOMS HAD RESOLVED WITHOUT MEDICAL EVAL OR INTERVENTION, AND PT WAS ASYMPTOMATIC AT TIME OF, AND DURING, THEIR 7TH PROSORBA TREATMENT. 36-48 HOURS AFTER LAST TREATMENT THE PT WAS ADMITTED TO THE HOSP WITH SEVERE CHEST PAIN AND SHORTNESS OF BREATH. A PERFUSION SCAN REVEALED A LARGE DEFICIT IN THE LEFT LUNG SUGGESTIVE OF PULMONARY EMBOLISM. A CHEST X-RAY WAS APPARENTLY NORMAL. PT HAD A CENTRAL CATHETER AND WHEN PT INITIALLY PRESENTED THEY HAD A LOW GRADE FEVER ASSOCIATED WITH ELEVATED WHITE BLOOD CELLS. ONE CULTURE OF THE CATHER WAS DRAWN UPON ADMISSION, AND IT WAS POSITIVE FOR GRAM + COCCI. ALL SUBSEQUENT CULTURES WERE NEGATIVE (WHILE PT WAS RECEIVING ANTIBIOTICS). LINE WAS REMOVED, AND PT'S FEVER AND ELEVATED WHITE BLOOD CELLS RESPONDED RAPIDLY TO INTRAVENOUS ANTIBIOTICS. THE PT WAS PLACED ON ANTICOAGULATION AN SYMPTOMS RESPONDED WELL. THE PT WAS ALSO TREATED FOR PLEURITIS WITH NON-STEROIDAL ANTI-INFLAMMATORY DRUG AND RESPONDED WELL. PT WAS SUBSEQUENTLY DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSORBA COLUMN PROTEIN A IMMUNOADSORPTION COLUMN LQQ CYPRESS BIOSCIENCE, INC. NA 032900A

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization INSULIN, MOTRIN, PERCACET, SYNTHROID.