BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN./EXT. DL

    MDR report key: 3130307 · Received May 22, 2013

    Report

    Report Number
    8030665-2013-00309
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    April 28, 2013
    Report Date
    April 28, 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 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 THE DIALYSIS SOLUTION WAS LEAKING OUT OF THE PT CONNECTOR. PT STATES THAT SHE UNSCREWED HER PT CONNECTOR FROM THE EXTENSION SET IN HER SLEEP DURING DRAIN THREE OF FOUR AND WOKE UP WHEN THE BED WAS VERY WET. PROPHYLACTIC ANTIBIOTICS WERE ADMINISTERED AS A PRECAUTION AND THE PATIENT HAD ON ADVERSE EFFECTS. SAMPLE IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226508 LIBERTY CYCLER SET, SINGLE CONN./EXT. DL FKX REYNOSA MANUFACTURING 13BR08828

    Patients

    Seq Age Sex Outcome Treatment
    1 LIBERTY DIALYSIS CYCLER