BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER

    MDR report key: 4230797 · Received October 24, 2014

    Report

    Report Number
    2937457-2014-03035
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 24, 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 DEPT OF THE TREATMENT DATA PROVIDED. A LARGE INTRA-PERITONEAL DRAIN VOLUME OCCURRED IN DRAIN FOUR WITH AN UNDETERMINED CAUSE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS REPORTED LARGE DRAIN. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE PLANT'S INVESTIGATION.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PT CALLED TECHNICAL SUPPORT WITH DRAIN COMPLICATIONS. UPON REVIEW OF THE CYCLER DATA AN OVERFILL WAS NOTED. (B)(6). IN CYCLE 1 THE PT DRAINED 3305 ML WHICH WAS 194% OVER THE EXPECTED DRAIN VOLUME RESULTING IN A REPORTABLE DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678333 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 PD SOLUTION| LIBERTY TUBING