BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRESENIUS DIALYZER-OGDEN

    MDR report key: 2841911 · Received November 14, 2012

    Report

    Report Number
    1225714-2012-00004
    Event Type
    Injury
    Date Received
    November 14, 2012
    Report Date
    October 22, 2012
    Manufacturer
    OGDEN MANUFACTURING
    Product Code
    KDI
    PMA / PMN Number
    K864587
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AMERICAN JOURNAL OF KIDNEY DISEASE.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE NOTED THAT DURING A HEMODIALYSIS TREATMENT, THE PATIENT EXPERIENCED A THROMBOCYTOPENIC EVENT USING AN OPTIFLUX DIALYZER (TYPE UNKNOWN). THE PATIENT'S PRE TREATMENT PLATELET COUNT WAS 180 AND THE POST TREATMENT PLATELET COUNT WAS 37. UPON CHANGING THE DIALYZER TO THE REXEED SX ELECTRON BEAM DIALYZER, THE PATIENT'S POST TREATMENT PLATELET COUNT WAS 147.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRESENIUS DIALYZER-OGDEN HEMODIALYSIS DIALYZER KDI OGDEN MANUFACTURING

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other