BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN./EXT DL

    MDR report key: 2852167 · Received November 12, 2012

    Report

    Report Number
    8030665-2012-00338
    Event Type
    Malfunction
    Date Received
    November 12, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 18, 2012
    Manufacturer
    REYNOSA MFG
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    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 MFG RECORDS WAS CONDUCTED BY THE MFR. THERE WERE NO DEVIATIONS OR NONCONFORMANCES DURING THE MFG 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 IS LEAKING OUT OF THE CASSETTE AND INTO THE CYCLER. IT WAS NOTICED THAT THERE WAS MOISTURE INSIDE THE CYCLER AFTER TREATMENT ENDED. THERE IS NO ILL EFFECTS TO THE PT. THE SAMPLE WAS DISCARDED AND IS NOT AVAILABLE FOR EVAL.

    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 MFG 12KR08002

    Patients

    Seq Age Sex Outcome Treatment
    1 LIBERTY DIALYSIS CYCLER