BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX 160NRE DIALYZER FIN

    MDR report key: 3123876 · Received May 15, 2013

    Report

    Report Number
    1713747-2013-00143
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 22, 2013
    Product Code
    FJI
    PMA / PMN Number
    K002671
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE CURRENTLY AVAILABLE INFORMATION, NO DEFINITIVE CONCLUSION CAN BE DRAWN. IT WAS REPORTED THAT DURING DIALYSIS TREATMENT THE ALARM SOUNDED AND THE TMP SHOT UP. A BLOOD LEAK WAS THEN VISUALIZED. FOLLOW-UP WITH THE USER FACILITY REPORTED THAT THE PATIENT HAD A CLOT IN CATHETER OR FISTULA CAUSING A BLOCKAGE. THE PATIENT DID NOT REQUIRE ANY INTERVENTION AND CONTINUES DIALYSIS TREATMENT WITH NO COMPLICATIONS. THE SAMPLE WAS NOT RETURNED FOR EVALUATION. IF ADDITIONAL INFORMATION IS PROVIDED A SUPPLEMENTAL REPORT WILL BE SUBMITTED. FOR INFORMATION REGARDING THE SECOND DIALYZER USED, SEE MDR # 1713747-2013-00142.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE PATIENT WAS HOOKED UP TO THE MACHINE, ALARMS WENT OFF, AND BLOOD WENT THROUGH THE DIALYZER INTO THE MACHINE. "PATIENT MAY HAVE BEEN PROBLEM, THEY USED 2 DIALYZERS AND THE SAME THING HAPPENED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215016 OPTIFLUX 160NRE DIALYZER FIN FJI 13AU01017

    Patients

    Seq Age Sex Outcome Treatment
    1