BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSORBA COLUMN

    MDR report key: 623033 · Received July 26, 2005

    Report

    Report Number
    3032792-2005-00013
    Event Type
    Malfunction
    Date Received
    July 26, 2005
    Date of Event
    May 27, 2005
    Report Date
    July 25, 2005
    Manufacturer
    FRESENIUS HEMOCARE
    Product Code
    LQQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED WITH CHEST PAIN AND SOB. PULMONARY EMBOLISM RULED OUT. PT DISCHARGED FROM HOSP AFTER 2-3 DAYS. MULTIPLE ATTEMPTS TO OBTAIN DIAGNOSTIC INFORMATION REGARDING THIS PT'S HOSPITALIZATION HAVE BEEN UNSUCCESSFUL SO FAR. THE PT DID NOT CONTINUE WITH ADDITIONAL PROSORBA TREATMENTS PER RECOMMENDATION FROM FHC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSORBA COLUMN PROTEIN A IMMUNOADSORPTION COLUMN LQQ FRESENIUS HEMOCARE 9798701 QKN0018

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization