BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN/EXT DL

    MDR report key: 3832999 · Received March 25, 2014

    Report

    Report Number
    8030665-2014-00244
    Event Type
    Malfunction
    Date Received
    March 25, 2014
    Date of Event
    February 27, 2014
    Report Date
    February 27, 2014
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MFR FOR PHYSICAL EVALUATION AND THE FAILURE MODE CANNOT BE CONFIRMED. HOWEVER, AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURE. 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

    A PERITONEAL DIALYSIS PATIENT HAS REPORTED THAT DIALYSIS SOLUTION WAS LEAKING OUT OF THE CASSETTE AND INTO THE CYCLER. UPON OPENING THE CASSETTE DOOR, THE PT'S MOTHER NOTICED FLUID LEAKING FROM A RUPTURE ON THE TUBING SET. PT HAD NO ADVERSE EFFECTS, HIS EFFLUENT REMAINED CLEAR AND REQUIRED NO MEDICATION INTERVENTION. SAMPLE IS NOT AVAILABLE; SAMPLE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173776 LIBERTY CYCLER SET, SINGLE CONN/EXT DL FKX REYNOSA MANUFACTURING 13NR08049

    Patients

    Seq Age Sex Outcome Treatment
    1 LIBERTY DIALYSIS CYCLER