BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX 180NRE DIALYZER FINISHED ASSY.

    MDR report key: 3140050 · Received May 29, 2013

    Report

    Report Number
    1713747-2013-00160
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 2013
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVAL, AND THE FAILURE MODE CANNOT BE CONFIRMED. HOWEVER, AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NONCONFORMANCES DURING THE MANUFACTURING PROCESS. IN ADDITION, THE BATCH RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION. FOR INFO RELATED TO THE SECOND EVENT SEE MDR # 1713747-2013-00161.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED BY THE USER FACILITY: DURING TREATMENT A BLOOD LEAK WAS OBSERVED. THE LEAK OCCURRED ON THE SAME PT ON TWO DIFFERENT TREATMENT DAYS. THE LEAK WAS DETECTED IN THE DIALYSATE AND MACHINE ALARMED. THE PT IS DOING WELL AND RECEIVED NO INTERVENTION, AND/OR ANTIBIOTICS AS A RESULTS OF THE BLOOD LOSS. PT EBL WAS 200 CC. SAMPLE HAS BEEN DISCARDED BY USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237520 OPTIFLUX 180NRE DIALYZER FINISHED ASSY. FJI 13BU04016

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR