BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN./ EXT. DL

    MDR report key: 3243173 · Received July 18, 2013

    Report

    Report Number
    8030665-2013-00459
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 23, 2013
    Report Date
    June 23, 2013
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    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 MFR. 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 PATIENT CONNECTOR. PATIENT WAS IN FILL FOUR OF TREATMENT. PATIENT CALLED IN WITH FILL COMPLICATIONS AND WHEN PULLING THE PIN OUT ON THE PATIENT CONNECTOR, THE PIN WAS REMOVED AND STARTED TO EXPEL FLUID. PATIENT DID NOT RECEIVE ANY PROPHYLACTIC ANTIBIOTICS AND HAS HAD NO ADVERSE EFFECTS. SAMPLE HAS NOT BEEN RETURNED TO THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336434 LIBERTY CYCLER SET, SINGLE CONN./ EXT. DL FKX REYNOSA MANUFACTURING 13CR08815

    Patients

    Seq Age Sex Outcome Treatment
    1 LIBERTY DIALYSIS CYCLER