BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX 180NRE DIALYZER FINISHED ASSY.

    MDR report key: 3140051 · Received May 29, 2013

    Report

    Report Number
    1713747-2013-00159
    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
    MS, 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.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT DURING TREATMENT OF A PT AN INTERNAL BLOOD LEAK WAS NOTIFIED. SPECIFICALLY, BLOOD WAS SEEN IN THE DIALYSATE LINES. NO DAMAGE WAS IDENTIFIED OR OTHER LEAKS. BLOOD TEST STRIPS WERE NOT USED, THOUGH THE MACHINE DID ALARM. PT WAS ESTIMATED TO LOSE LESS THAN 20 CC OF BLOOD; HOWEVER, THE PT HAD NO ADVERSE EFFECTS DUE TO LEAK COMPLICATIONS. BLOOD FLOW RATE - 400; DIALYSATE FLOW RATE - 800. SAMPLE WAS DISCARDED BY USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233910 OPTIFLUX 180NRE DIALYZER FINISHED ASSY. FJI 13AU02007

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR MACHINE MODEL - K2