BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER

    MDR report key: 3962596 · Received June 30, 2014

    Report

    Report Number
    2937457-2014-01471
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    May 30, 2014
    Report Date
    May 30, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, IT IS UNK HOW THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE PLANT INVESTIGATION IS PENDING. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A PERITONEAL NURSE CALLED INTO TECHNICAL SUPPORT TO REPORT USED EFFLUENT HAD MIGRATED BACK TO EMPTY SOLUTION BAGS AFTER PATIENT HAD COMPLETED TREATMENT, DISCONNECTED, AND EMPOWERED THE CYCLER OFF. THE CLAMPS REMAINED OPEN DURING THIS TIME. A REVIEW OF THE TREATMENT DATA REVEALED IN DRAIN 5 AN OVERFILL HAD OCCURRED WHICH RESULTED IN A DRAIN VOLUME 182% LARGER THAN THE PRESCRIBED FILL VOLUME. ACCORDING TO THE PERITONEAL DIALYSIS NURSE, THE PATIENT DID NOT REQUIRE MEDICAL INTERVENTION. THE CYCLER HAS BEEN RETURNED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378843 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 LIBERTY CYCLER SET, FRESENIUS PD SOLUTION