BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX 60NRE DIALYZER FINISHED ASSY.

    MDR report key: 3911952 · Received May 13, 2014

    Report

    Report Number
    1713747-2014-00240
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 16, 2014
    Manufacturer
    OGDEN MANUFACTURING
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PLANT INVESTIGATION HAS NOT YET BEEN COMPLETED. A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A HEMODIALYSIS INPATIENT USER FACILITY HAS REPORTED THAT DURING TREATMENT, A BLOOD LEAK OCCURRED. FACILITY STATED THAT UPON INITIATING PT TREATMENT (TREATMENT NOT ACTUALLY STARTED), THE PATIENT CARE TECHNICIAN NOTICED PINKISH COLOR OOZING INTO THE HANSON LINE CONNECTED TO THE DIALYZER. TREATMENT WAS IMMEDIATELY STOPPED AND PT'S BLOOD WAS NOT RETURNED DUE TO POTENTIAL CONTAMINATION. PT WAS MOVED TO ANOTHER MACHINE, AND COMPLETED TREATMENT WITHOUT DIFFICULTY. ESTIMATED BLOOD LOSS WAS LESS THAN 100CC'S. PT DID NOT REQUIRE ANY MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285297 OPTIFLUX 60NRE DIALYZER FINISHED ASSY. FJI OGDEN MANUFACTURING 13SU06017

    Patients

    Seq Age Sex Outcome Treatment
    1 FRESENIUS 2008K MACHINE