BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XENIUM DIALYZER

    MDR report key: 1160482 · Received September 12, 2008

    Report

    Report Number
    1423500-2008-00796
    Event Type
    Injury
    Date Received
    September 12, 2008
    Date of Event
    August 18, 2008
    Report Date
    August 25, 2008
    Manufacturer
    NIPRO CORPORATION
    Product Code
    KDI
    PMA / PMN Number
    K062079
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REQUEST FOR THE RETURN OF THE SAMPLE HAS BEEN MADE. SHOULD A SAMPLE BE RECEIVED FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    INTERNATIONAL FACILITY FROM BRAZIL REPORTED: IN 2008, AFTER THE FIRST SESSION OF HEMODIALYSIS, A PATIENT WITH CHRONIC KIDNEY DISEASE EXPERIENCED THORACIC PAIN AT HOME AFTER THERAPY USING A XENIUM DIALYZER. THE PATIENT WAS DIAGNOSED WITH PLEURAL EFFUSION THROUGH X-RAY OF THE CHEST. THE PATIENT WAS ADMITTED IN THE HOSPITAL ON THE NEXT DAY, AND CURRENTLY REMAINS HOSPITALIZED. THIS PATIENT IS PATIENT NUMBER 1 OF DIALYSIS CENTER 1 ON A STUDY TO DETERMINE THE EFFECT OF MANUAL REPROCESSING WITH PERACETIC ACID AFFECTING THE PERFORMANCE OF THE XENIUM LF 190 DIALYZER. THE INVESTIGATOR DOES NOT CONSIDER THAT THE EVENT LINKS WITH THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XENIUM DIALYZER 78KDI KDI NIPRO CORPORATION 08A10SX

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R ASPIRIN 200 MG| ATENOLOL 50 MG| OMEPRAZOLE 20 MG| PROPALTYNITRATE 20 MG| SEVELAMER CHLORIDE 800 MG| INSULIN NPH 16 U| ATORVASTATIN 20 MG| ANLODIPINE 5 MG| EPOGEN 8000 IU