BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIBERTY CYCLER

    MDR report key: 3969900 · Received April 25, 2014

    Report

    Report Number
    2937457-2014-00712
    Event Type
    Other
    Date Received
    April 25, 2014
    Date of Event
    March 27, 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 LARGE INTRA-PERITONEAL DRAIN VOLUME OCCURRED DURING A MANUAL DRAIN, THE MORNING AFTER THE LAST FILL VOLUME. THE CASE OF THE LARGE DRAIN VOLUME IS UNK. 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. BASED ON THE INFO PROVIDED, IT IS UNK HOW THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE POST MARKET SURVEILLANCE DÉPARTEMENT HAS REVIEWED MEDICAL RECORDS AND INVESTIGATIONS ARE PENDING.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) PT REPORTED A DRAIN ISSUE DURING TREATMENT. THE PT REMAINED ASYMPTOMATIC: LAST FILL VOLUME: 160ML; DRAIN: 3200ML. ON (B)(6) 2014, THE PT EXPERIENCED AN EPISODE OF INCREASED INTRAPERITONEAL VOLUME (IIPV), WHEN HE PERFORMED A MANUAL DRAIN IN THE MORNING AND 3200 ML OF EFFLUENT WAS EXPRESSED FROM THE PT'S PERITONEAL DIALYSIS CATHETER. THE PT'S LAST FILL VOLUME WAS 1600ML. THE REPORTED DRAIN VOLUME OF 3200ML WAS 200% 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
    251041 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR LIBERTY CYCLER CASSETTE