BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX 160NRE DIALYZER FINISHED ASY

    MDR report key: 3833021 · Received March 25, 2014

    Report

    Report Number
    1713747-2014-00145
    Event Type
    Malfunction
    Date Received
    March 25, 2014
    Date of Event
    February 27, 2014
    Report Date
    March 3, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. TEST STRIPS WERE USED TO CONFIRM AND THE MACHINE ALARMED MINOR LEAK. THE LEAK WAS NOT VISUALLY OBSERVED IN THE DIALYSATE. THE WASTE WATER FROM MACHINE TESTED POSITIVE. DURING A FOLLOW UP WITH THE CLINIC MANAGER, IT WAS REPORTED THAT THE PATIENT DID NOT EXPERIENCE ANY BLOOD LOSS. THE PATIENT WAS SWITCHED TO A DIFFERENT MACHINE TO COMPLETE TREATMENT. PATIENT HAD NO ADVERSE EFFECTS AND NO MEDICAL INTERVENTION WAS REQUIRED. SAMPLE HAS NOT BEEN RETURNED TO MANUFACTURER. DUE TO THE INITIAL REPORT OF THE BLOOD TEST STRIPS CONFIRMING A LEAK, A MALFUNCTION MDR WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173731 OPTIFLUX 160NRE DIALYZER FINISHED ASY FJI FRESENIUS MEDICAL CARE NORTH AMERICA 13SU06017

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR 2008T HEMODIALYSIS MACHINE