BEUDAMED
    FDA Adverse Event Injury Summary report: N

    U0308 XENIUM 210G SYNTH HFDIALYZER

    MDR report key: 1243944 · Received November 25, 2008

    Report

    Report Number
    1423500-2008-00935
    Event Type
    Injury
    Date Received
    November 25, 2008
    Date of Event
    November 5, 2008
    Report Date
    November 7, 2008
    Manufacturer
    NIPRO CORPORATION
    Product Code
    KDI
    PMA / PMN Number
    K062079
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE FACILITY REPORTED A PT EXPERIENCED EPIGASTRIC PAIN/NAUSEA & VOMITING AND HAEMATEMESIS (HEMOPTYSIS) AT HOME (DATE UNK) SHORTLY AFTER RECEIVING DIALYSIS AT THE RENAL UNIT USING A XENIUM DIALYZER. THE PT WAS ADMITTED TO THE SURGICAL WARD (DATE UNK). THE BLOOD TESTS (REPEATED X3) INDICATED THE PT WAS SEVERELY HAEMOLYSED (HEMOLYSIS). THE CONSULTANT WAS INFORMED AND THE PT WAS TRANSFERRED TO BELFAST CITY HOSPITAL (DATE UNK). THE PT STATUS IS UNK AT THIS TIME. IT IS UNK IF THE SAMPLE IS AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U0308 XENIUM 210G SYNTH HFDIALYZER 78KDI KDI NIPRO CORPORATION 08F05S

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention