BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX 180NRE DIALYZER FINISHED ASSY.

    MDR report key: 3070555 · Received April 17, 2013

    Report

    Report Number
    1713747-2013-00094
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    February 23, 2013
    Report Date
    March 21, 2013
    Manufacturer
    OGDEN MANUFACTURING
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A HEMODIALYSIS USER FACILITY HAS REPORTED THAT DURING TREATMENT A BLOOD LEAK OCCURRED. DURING TREATMENT, THE LEAK OCCURRED AROUND TOP HEADER CAP THREADS. ESTIMATED BLOOD LOSS WAS LESS THAN 20 CC'S. THE MACHINE DID NOT ALARM. NO MEDICAL INTERVENTION WAS REQUIRED, THE PT HAD NO ADVERSE EFFECTS FROM THE INCIDENT. SAMPLE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165414 OPTIFLUX 180NRE DIALYZER FINISHED ASSY. HEMODIALYSIS DIALYZER FJI OGDEN MANUFACTURING 12SU06020

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR FRESENIUS T MACHINE