BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET

    MDR report key: 3930060 · Received March 10, 2014

    Report

    Report Number
    8030665-2014-00214
    Event Type
    Malfunction
    Date Received
    March 10, 2014
    Date of Event
    February 5, 2014
    Report Date
    February 6, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE PLANT'S INVESTIGATION.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) PATIENT REPORTED DIALYSIS SOLUTION LEAKED OUT OF CASSETTE AND INTO THE CYCLER. UPON REMOVING THE TUBING SET, POST TREATMENT, THE PATIENT FOUND FLUID IN THE CYCLER. THERE WERE NO PROPHYLACTIC ANTIBIOTICS ADMINISTERED. THE PATIENT'S EFFLUENT REMAINED CLEAR AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142802 LIBERTY CYCLER SET FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 LIBERTY CYCLER