BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER

    MDR report key: 3950800 · Received June 13, 2014

    Report

    Report Number
    2937457-2014-01022
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 15, 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 PATIENT CALLED IN TO REPORT A DRAIN COMPLICATION ALARM. THE PATIENT'S CYCLER HISTORY WAS REVIEWED, AND AN OVERFILL WAS NOTED. DRAIN 0: 2315; FILL 1: 2203, DRAIN 1: 2309; FILL 2: 2203, DRAIN 2: 1745; FILL 3: 2203, DRAIN 3: 4000; FILL 4: 1900. THE REPORTED DRAIN VOLUME OF 4000 ML WAS 182% OVER THE EXPECTED DRAIN VOLUME WHICH RESULTED IN A REPORTABLE DEVICE MALFUNCTION. THE PATIENT DID NOT REQUIRE MEDICAL INTERVENTION OR TREATMENT AS A RESULT OF THE OVERFILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350733 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 LIBERTY TUBING| PD SOLUTION