BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    F6 DIALYZER FINISHED ASSY (CASE)

    MDR report key: 1900290 · Received October 25, 2010

    Report

    Report Number
    1713747-2010-00045
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    August 19, 2010
    Report Date
    October 25, 2010
    Manufacturer
    OGDEN MFG
    Product Code
    FJI
    PMA / PMN Number
    K874872
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE INITIAL REPORT WAS RECEIVED ON (B)(6) 2010. ADDITIONAL INFO RECEIVED ON THE EVENT OCCURRED ON (B)(6) 2010. IT WAS ALSO REPORTED THAT THE INVOLVED PT WAS AN ADULT.

    Description of Event or Problem · 1

    RECEIVED A REPORT OF AN INTERNAL DIALYZER LEAK. IT WAS LEARNED ON (B)(6) 2010 IN SPEAKING WITH THE RPTR OF THE EVENT THAT THIS DIALYZER WAS USED ON A MEDICALLY FRAGILE PT. THE MD ORDERS THIS DIALYZER DUE TO THE PT BEING NEW TO DIALYSIS AND A FRAGILE CARDIAC STATUS. ATTEMPTS HAVE BEEN MADE IN ORDER TO IDENTIFY THE ESTIMATED BLOOD LOSS, BUT NO FURTHER INFO HAS BEEN RECEIVED. THE FACILITY HAS NOT REPORTED ANY ILL EFFECT OR HARM TO THE PT AS A RESULT OF THIS EVENT. A COMPANION SAMPLE IS AVAILABLE FOR AN EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 F6 DIALYZER FINISHED ASSY (CASE) DIALYZER FJI OGDEN MFG NA 10AU03015

    Patients

    Seq Age Sex Outcome Treatment
    1 NA