BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSORBA COLUMN

    MDR report key: 96953 · Received June 5, 1997

    Report

    Report Number
    3023288-1997-00006
    Event Type
    Injury
    Date Received
    June 5, 1997
    Date of Event
    May 5, 1997
    Report Date
    June 5, 1997
    Manufacturer
    CYPRESS BIOSCIENCE, 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

    THE PATIENT WITH A DIAGNOSIS OF IDIOPATHIC THROMBOCYTOPENIC PURPURA (ITP) WAS TREATED WITH HIS FIRST PROSORBA COLUMN TREATMENT ON 05/05/97. APPROXIMATELY 250CC OF TREATED PLASMA HAD BEEN RETURNED TO THE PATIENT WHEN THE PATIENT COMPLAINED OF TINGLING THEN BURNING IN HIS HANDS AND DIFFICULTY BREATHING. THE REINFUSION RATE WAS 12-15 ML/MIN.THE TREATMENT WAS PAUSED AND THE SYMPTOMS ABATED. THE TREATMENT WAS RESUMED BUT THE BURNING SENSATION IN THE PATIENT'S HANDS RETURNED. THE PATIENT COMPLAINED OF NAUSEA, EXPERIENCED FACIAL FLUSHING AND HYPOTENSION. THE TREATMENT WAS DISCONTINUED. THE NURSE LEARNED UPON QUESTIONING THE PATIENT THAT THE PATIENT HAD BEEN TAKING AN ANGIOTENSION CONVERTING ENZYME (ACE) INHIBITOR MEDICATION, ACCUPRIL. USE OF THE PROSORBA COLUMN IS CONTRAINDICATED IN PATIENTS RECEIVING ACE INHIBITOR MEDICATIONS. THE NURSE STATED THAT THE PATIENT WAS NEW TO HER AND THE SHE FORGOT TO CHECK THE MEDICATIONS THE PATIENT WAS TAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSORBA COLUMN PROTEIN A IMMUNOADSORPTION COLUMN LQQ CYPRESS BIOSCIENCE, INC. NA 020697B

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention