BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN./EXT. DL

    MDR report key: 3745851 · Received January 24, 2014

    Report

    Report Number
    8030665-2014-00103
    Event Type
    Malfunction
    Date Received
    January 24, 2014
    Date of Event
    November 29, 2013
    Report Date
    January 3, 2014
    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 AND CARTRIDGE HAVE NOT BEEN RETURNED FOR EVALUATION AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE PLANT'S INVESTIGATION. RELATED COMPLAINTS: 8030665-2013-00873, 8030665-2013-00937, 8030665-2014-001007, 8030665-2014-0053, 8030665-2014-00086, 8030665-2014-00102, 8030665-2014-00103 AND 8030665-2014-00104.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) PATIENT REPORTED AN AIR CASSETTE ALARM TOWARDS END OF TREATMENT. A FLUID LEAK WAS IDENTIFIED NEAR THE CYCLER DOOR. THERE WAS A HOLE ON THE SEAL OF THE CARTRIDGE NEAR THE CONE PART. THE PATIENT FINISHED THE TREATMENT WITH MANUAL EXCHANGE. HER EFFLUENT FLUID WAS CLEAR. NO PROPHYLACTIC ANTIBIOTICS WERE USED SINCE THE PATIENT WAS RECENTLY TAKING CEFAZOLIN DUE TO A FLUID LEAK 2 DAYS PREVIOUS. THE PATIENT HAS NOT REPORTED ANY ADVERSE EVENT ASSOCIATED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57796 LIBERTY CYCLER SET, SINGLE CONN./EXT. DL FKX REYNOSA MANUFACTURING

    Patients

    Seq Age Sex Outcome Treatment
    1 LIBERTY CYCLER