BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSORBA COLUMN

    MDR report key: 619414 · Received June 30, 2005

    Report

    Report Number
    3032792-2005-00011
    Event Type
    Injury
    Date Received
    June 30, 2005
    Date of Event
    May 31, 2005
    Report Date
    June 30, 2005
    Manufacturer
    FRESENIUS HEMOCARE
    Product Code
    LQQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT DIAGNOSED WITH POPLITEAL ARTERY THROMBOSIS THE DAY AFTER THEIR FIRST TREATMENT FOR RHEUMATOID ARTHRITIS. IT WAS ALSO FOUND ONE THAT DAY THAT THEIR DIALYSIS SHUNT HAD OCCLUDED. THE DAY PRIOR TO THEIR PROSORBA TREATMENT, IT IS STATED THAT THEIR DIALYSIS LEFT THEM IN A MORE NEGATIVE FLUID BALANCE THAN USUAL WHICH LED TO THEIR HAVING A LOW BLOOD PRESSURE ON THE DAY OF PROSORBA. THIS PT ALSO IS STATED TO HAVE "SEVERE ARTERIAL OBSTRUCTIVE DISEASE FROM THEIR DIABETES AND WAS NOT TAKING ASPIRIN DUE TO HEMATOCHEZIA SECONDARY TO HEMORRHOIDS. LASTLY, THEY WERE TAKING UP TO 50 MG OF CORTISONE/DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSORBA COLUMN IMMUNOADSORPTION COLUMN LQQ FRESENIUS HEMOCARE 9798701 RAN001

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization