BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, DUAL PATIENT CONNECT

    MDR report key: 3042855 · Received April 4, 2013

    Report

    Report Number
    8030665-2013-00179
    Event Type
    Malfunction
    Date Received
    April 4, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 6, 2013
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    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 R.N. HAS REPORTED THAT DIALYSIS SOLUTION WAS LEAKING OUT OF THE CASSETTE AND INTO THE CYCLER. PATIENT WAS MID TREATMENT. UPON REMOVING THE TUBING SET, MOISTURE WAS NOTICED INSIDE THE CYCLER. PATIENT DID NOT RECEIVE ANY ANTIBIOTICS AND HAD NO ILL EFFECTS. SAMPLE WAS DISCARDED BY THE USER FACILITY; SAMPLE IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138373 LIBERTY CYCLER SET, DUAL PATIENT CONNECT LIBERTY DIALYSIS CYCLER TUBING FKX REYNOSA MANUFACTURING 12HR08095

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR LIBERTY DIALYSIS CYCLER