BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER

    MDR report key: 3882838 · Received April 4, 2014

    Report

    Report Number
    2937457-2014-00537
    Event Type
    Malfunction
    Date Received
    April 4, 2014
    Date of Event
    March 3, 2014
    Report Date
    March 27, 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 REVIEW WAS PERFORMED BY THE POST MARKET CLINICAL DEPARTMENT OF THE TREATMENT DATA PROVIDED. A LARGE INTRA-PERITONEAL DRAIN VOLUME OCCURRED IN DRAIN 3 WITH AN UNDERMINED CAUSE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS REPORTED LARGE DRAIN VOLUME. THE DEVICE WAS NOT RETURNED TO THE MFR FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) NURSE REPORTED A PT EXPERIENCED DRAIN ISSUES DURING TREATMENT. THE PT REMAINED ASYMPTOMATIC: DRAIN 0: 1434ML; FILL 1: 2496ML , DRAIN 1: 1817ML; FILL 2: 2496ML, DRAIN 2: 1961ML; FILL 3: 2496ML, DRAIN 3: 5079ML; FILL 4: 2496ML, DRAIN 4: 3239ML; FILL 5: 2496ML LAST FILL VOLUME. THE REPORTED DRAIN VOLUME OF 5079 ML WAS 203% OVER THE EXPECTED DRAIN VOLUME WHICH RESULTED IN A REPORTABLE DEVICE MALFUNCTION. THE PT DID NOT REQUIRE MEDICAL INTERVENTION OR TREATMENT AS A RESULT OF THE OVERFILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205159 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 LIBERTY CYCLER CASSETTE