BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN./EXT.DL

    MDR report key: 2852164 · Received November 12, 2012

    Report

    Report Number
    8030665-2012-00341
    Event Type
    Malfunction
    Date Received
    November 12, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 22, 2012
    Manufacturer
    REYNOSA MFG
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT IS CONFIRMED WITH RETURNED DEVICE. A BATCH RECORD REVIEW WAS ALSO CONDUCTED AND CONFIRMED THERE WERE NO DEVIATIONS OR NONCONFORMANCES DURING THE MFG PROCESS. PRODUCT 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. PATIENT REMOVED THE TUBING SET FROM THE CYCLER AND NOTICED FLUID COMING FROM THE BOTTOM OF THE CASSETTE AND MOISTURE INSIDE THE CYCLER DOOR. PT WAS IN DRAIN THREE OF FIVE. PATIENT STATES THAT HE HAS TAKEN ANTIBIOTICS AS A PRECAUTION AND HAS NOTICED NO ILL EFFECTS. THERE IS A SAMPLE 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 12HR08007

    Patients

    Seq Age Sex Outcome Treatment
    1 LIBERTY DIALYSIS CYCLER