BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, DUAL PATIENT CONNECT

    MDR report key: 3131496 · Received May 14, 2013

    Report

    Report Number
    8030665-2013-00281
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 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 ACTUAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION, HOWEVER, A COMPANION SAMPLE FROM THE SAME LOT WAS RETURNED FOR INVESTIGATION AND NO DEFECTS WERE NOTED. IN ADDITION, AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NONCONFORMANCE 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 REMOVING THE TUBING SET FOLLOWING TREATMENT, FLUID WAS LEAKING FROM THE CASSETTE DOOR OF THE CYCLER. PATIENT DID NOT RECEIVE AN ANTIBIOTICS AND HAD NO ADVERSE EFFECTS. A COMPANION SAMPLE OF THE SAME LOT NUMBER IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213768 LIBERTY CYCLER SET, DUAL PATIENT CONNECT FKX REYNOSA MANUFACTURING 13AR08812

    Patients

    Seq Age Sex Outcome Treatment
    1 LIBERTY DIALYSIS CYCLER