BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN./EXT DL

    MDR report key: 2864703 · Received December 6, 2012

    Report

    Report Number
    8030665-2012-00379
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 11, 2012
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Removal / Correction Number
    NA
    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 FAILURE MODE CAN NOT 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 THE DIALYSIS SOLUTION IS LEAKING OUT OF THE CASSETTE AND INTO THE CYCLER. PT NOTICED FLUID INSIDE THE CYCLER WHEN SHE REMOVED THE CASSETTE FOLLOWING TREATMENT. RN AT PT'S CLINIC STATES THAT PT DID NOT RECEIVE ANY ANTIBIOTICS AND HAS HAD NO ILL EFFECTS. SAMPLE HAS NOT BEEN RETURNED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTY CYCLER SET, SINGLE CONN./EXT DL LIBERTY DIALYSIS CYCLER TUBING FKX REYNOSA MANUFACTURING 12KR08050

    Patients

    Seq Age Sex Outcome Treatment
    1 LIBERTY DIALYSIS CYCLER