BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN./EXT.DL

    MDR report key: 3963734 · Received May 7, 2014

    Report

    Report Number
    8030665-2014-00353
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 22, 2014
    Manufacturer
    REYNOSA PLANT
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PLANT INVESTIGATION HAS NOT YET BEEN COMPLETED. A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PT HAS REPORTED WHEN THE CYCLER DOOR WAS OPENED TO REMOVE TUBING SET FLUID LEAKED OUT. PROPHYLACTIC ANTIBIOTICS WERE ADMINISTERED AS A PRECAUTION, EFFLUENT REMAINED CLEAR AND THERE IS NO OTHER KNOWN PT IL EFFECT. SAMPLE AVAILABLE FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273380 LIBERTY CYCLER SET, SINGLE CONN./EXT.DL FKX REYNOSA PLANT 13PR08068

    Patients

    Seq Age Sex Outcome Treatment
    1 LIBERTY DIALYSIS CYCLER