BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER

    MDR report key: 4053371 · Received August 27, 2014

    Report

    Report Number
    2937457-2014-02352
    Event Type
    Malfunction
    Date Received
    August 27, 2014
    Date of Event
    July 29, 2014
    Report Date
    July 29, 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 AND REPORTED A LARGE DRAIN VOLUME. A FOLLOW UP CALL WAS MADE TO THE PATIENT'S PERITONEAL DIALYSIS NURSE AND SHE WAS NOT AWARE OF THE EVENT. THE PERITONEAL DIALYSIS NURSE REPORTS SEEING THE PATIENT THREE TIMES SINCE THE EVENT AND STATED THERE WAS NO INJURY. FILL 0; DRAIN: 128 ML. FILL 1 - 1707; DRAIN: 5696 ML. THE REPORTED DRAIN VOLUME OF 5696 ML WAS 335% 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
    522801 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 LIBERTY TUBING| PD SOLUTION