BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    F6 DIALYZER FINISHED ASSY

    MDR report key: 2142122 · Received May 26, 2011

    Report

    Report Number
    1713747-2011-00016
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 26, 2011
    Manufacturer
    OGDEN MANUFACTURING
    Product Code
    MSE
    PMA / PMN Number
    K970700
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    A REPORT HAS BEEN REC'D INDICATING THAT DURING DIALYSIS TREATMENT, AN INTERNAL BLOOD LEAK WAS DETECTED WITH THE USE OF THIS DIALYZER. REPORTEDLY, THIS IS AN INPATIENT WHO WAS IN THE TELEMETRY UNIT AND THE PT'S CONDITION WAS DESCRIBED AS BEING WEAK DUE TO CARDIAC ISSUES UNRELATED TO THIS EVENT. THE INCIDENT OCCURRED APPROX TEN TO FIFTEEN MINUTES INTO TREATMENT WITH AN ESTIMATED BLOOD LOSS OF 100-150 MLS. AN H & H WAS DRAWN AND OXYGEN WAS ADMINISTERED FOLLOWING THE EVENT. THE H & H WERE REPORTED AS BEING FINE. THE PT COMPLETED DIALYSIS WITH THE USE OF NEW PRODUCT AND A NEW MACHINE AND HAS SINCE DISCHARGED FROM THE HOSP. THE ADMISSION WAS UNRELATED AS THE PT WAS ADMITTED PRIOR TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 F6 DIALYZER FINISHED ASSY DIALYZER MSE OGDEN MANUFACTURING NA 10LU04011

    Patients

    Seq Age Sex Outcome Treatment
    1 NI