BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER

    MDR report key: 3950630 · Received June 6, 2014

    Report

    Report Number
    2937457-2014-00992
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 18, 2014
    Report Date
    June 4, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO INDICATION THAT THERE WAS ANY SERIOUS INJURY TO THE PT. DUE TO A POTENTIAL MALFUNCTION OF THE MACHINE, A MALFUNCTION MDR WILL BE FILED. A REVIEW WAS PERFORMED BY THE POST MARKET CLINICAL DEPARTMENT OF THE TREATMENT DATA PROVIDED BY THE NURSE. A LARGE INTRA-PERITONEAL VOLUME OCCURRED IN DRAIN 4 WITH AN UNDETERMINED CAUSE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF PLANT'S INVESTIGATION.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) NURSE REPORTED A PT EXPERIENCED DRAIN ISSUES DURING TREATMENT. THE PT REMAINED ASYMPTOMATIC: SEE SCANNED TABLE. THE REPORTED DRAIN VOLUME OF 4705 ML WAS 189% 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
    331847 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 LIBERTY CYCLER CASSETTE| DELFLEX PD SOLUTIONS