BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN./EXT DL

    MDR report key: 3240916 · Received July 17, 2013

    Report

    Report Number
    8030665-2013-00454
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 23, 2013
    Report Date
    June 25, 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 MANUFACTURER FOR PHYSICAL EVAL AND THE FAILURE MODE CANNOT BE CONFIRMED. HOWEVER, AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. 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 PT HAS REPORTED THAT DIALYSIS SOLUTION WAS LEAKING OUT OF THE CASSETTE AND INTO THE CYCLER. PT ALSO STATED THAT THERE WAS A HOLE ON THE MEMBRANE. PROPHYLACTIC ANTIBIOTICS WERE ADMINISTERED AS A PRECAUTION AND PT HAD NO ADVERSE EFFECTS. SAMPLES HAS NOT BEEN RETURNED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332823 LIBERTY CYCLER SET, SINGLE CONN./EXT DL FKX REYNOSA MANUFACTURING 13CR08821

    Patients

    Seq Age Sex Outcome Treatment
    1 LIBERTY DIALYSIS CYCLER