BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, DUAL PATIENT CONNECT

    MDR report key: 3964325 · Received June 19, 2014

    Report

    Report Number
    8030665-2014-00491
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE PLANT'S INVESTIGATION.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) NURSE REPORTED FINDING A FLUID LEAK FOLLOWING A SIMULATED TREATMENT. THE NURSE WAS TRAINING A PATIENT USING A "TUMMY DUMMY." THERE WERE NO ALARMS DURING THE SIMULATED TREATMENT. WHEN SHE WAS FINISHED WITH THE TREATMENT, SHE OPENED THE CASSETTE DOOR AND DISCOVERED A LEAK. THERE WAS A FLUID LEAKING FROM THE MEMBRANE ON THE BACK OF THE CASSETTE. SHE RETAINED THE SET AND IS MAKING IT AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359634 LIBERTY CYCLER SET, DUAL PATIENT CONNECT FKX REYNOSA MANUFACTURING

    Patients

    Seq Age Sex Outcome Treatment
    1 LIBERTY CYCLER