BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSORBA COLUMN

    MDR report key: 802843 · Received January 8, 2007

    Report

    Report Number
    3032792-2007-00001
    Event Type
    Injury
    Date Received
    January 8, 2007
    Date of Event
    November 21, 2006
    Report Date
    January 5, 2007
    Manufacturer
    FRESENIUS HEMOCARE
    Product Code
    LQQ
    PMA / PMN Number
    p850020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS A CLINICAL INVESTIGATION ONLY. RETURN OF PRODUCT NOT REQUESTED AS EVALUATION OF DEVICE AFTER USE NOT RELEVANT TO REPORTED EVENT. THE DEVICE WAS USED ACCORDING TO LABELED INDICATIONS AND IN THE APPROPRIATE ENVIRONMENT. TEMPORAL RELATIONSHIP OF THE EVENT OF PROSORBA MIGHT SUGGEST A CONTRIBUTORY RELATIONSHIP BECAUSE THE PATIENT WOULD NOT HAVE HAD THIS CENTRAL VENOUS CATHETER IF SHE HAD NOT BEEN UNDERGOING TREATMENTS WITH PROSORBA.

    Description of Event or Problem · 1

    AN RA PATIENT DEVELOPED RIGHT ARM AND HAND SWELLING THE EVENING AFTER HER 12TH PROSORBA TREATMENT. SHE WAS ADMITTED TO THE HOSPITAL AND DIAGNOSED WITH THROMBOSIS IN HER RIGHT INTERNAL JUGULAR VEIN WHERE HER CENTRAL VENOUS CATHETER WAS (IT WAS SCHEDULED FOR REMOVAL THE NEXT DAY). SHE WAS TREATED WITH ANTICOAGULANTS. THE CATHETER REMOVAL WAS PERFORMED THE NEXT DAY AND LATER THAT EVENING SHE DEVELOPED DYSPNEA AND CHEST PAIN. A CT THEN REVEALED BILATERAL PULMONARY EMBOLI. SHE WAS ALREADY ON A HEPARIN DRIP. SHE WAS DISCHARGED AFTER 6 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSORBA COLUMN IMMUNOADSORPTION COLUMN LQQ FRESENIUS HEMOCARE 9798701 RGN001D

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization CYTOTEC| OXYCONTIN| NEURONTIN| PROTONIX| LIDODERM| FELDENE| LEXAPRO| ARAVA| LYRICA| AMBIEN| BENICAR| KEPPRA| CLONIDINE| LASIX| ACYCLOVIR| ASPIRIN| DURAGESIC| MEDROL| HUMIRA| BACLOFEN