BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN./EXT/ DL

    MDR report key: 3952605 · Received May 15, 2014

    Report

    Report Number
    8030665-2014-00414
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 29, 2014
    Manufacturer
    REYNOSA PLANT
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 PERITONEAL DIALYSIS PATIENT'S DAUGHTER CONFIRMED THAT THERE WAS FLUID LEAKING FROM THE TUBING SET WHEN SHE OPENED THE CASSETTE DOOR. SHE IDENTIFIED ONE OF THE TUBING LINES AS THE SOURCE OF THE LEAK. THE LINES WERE WEDGED INSIDE THE CASSETTE DOOR AND ONE OF THE LINES WAS SLICED AS A RESULT. NO PROPHYLACTIC ANTIBIOTICS WERE PRESCRIBED. THE PATIENT'S EFFLUENT REMAINED CLEAR. PATIENT COMPLETED TREATMENT VIA MANUALS. THERE WERE NO OTHER KNOWN PATIENT ILL EFFECTS. THE SAMPLE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291226 LIBERTY CYCLER SET, SINGLE CONN./EXT/ DL FKX REYNOSA PLANT 13SR08008

    Patients

    Seq Age Sex Outcome Treatment
    1 LIBERTY DIALYSIS CYCLER