BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER

    MDR report key: 5697296 · Received June 3, 2016

    Report

    Report Number
    2937457-2016-00576
    Event Type
    Malfunction
    Date Received
    June 3, 2016
    Date of Event
    May 15, 2016
    Report Date
    July 21, 2016
    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

    (B)(4). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE PLANT¿S INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RECEIVED FOR EVALUATION, AND THE REPORTED PROBLEM WAS NOT CONFIRMED WITH TESTING. A VISUAL INSPECTION OF THE RETURNED CYCLER EXTERIOR SHOWED NO SIGN OF PHYSICAL DAMAGE. A SIMULATED TREATMENT WAS PERFORMED AND COMPLETED WITHOUT ANY FAILURES OR PROBLEMS. THE CYCLER WEIGHED FILL VOLUME VALUES WERE WITHIN TOLERANCE. THE CYCLER PROGRAMMED DISPLAYED FILL AND DRAIN VOLUME VALUES WERE WITHIN THE TOLERANCES. A SIMULATED TREATMENT WAS PERFORMED AND COMPLETED WITHOUT ANY FAILURES OR PROBLEMS. THE CYCLER PROGRAMMED DISPLAYED FILL AND DRAIN VOLUME VALUES WERE WITHIN THE TOLERANCES. THE VALVE ACTUATION TEST PASSED. THE SYSTEM AIR LEAK TEST PASSED. THE LOAD CELL VALUE AND VERIFICATION WERE WITHIN TOLERANCE. THE PATIENT SENSOR CALIBRATION CHECK PASSED. THERE WERE NO DISCREPANCIES ENCOUNTERED IN THE INTERNAL INSPECTION OF THE CYCLER. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES DURING THE MANUFACTURING PROCESS. IN ADDITION, THE DEVICE MANUFACTURING REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PATIENT CALLED TECHNICAL SUPPORT AND REPORTED A LARGE DRAIN VOLUME. TREATMENT DATA WAS REVIEWED WITH THE PATIENT WHICH REVEALED THREE LARGE DRAIN VOLUMES. A CALL WAS MADE TO THE PATIENT'S NURSE WHO REPORTED THE PATIENT REMAINED ASYMPTOMATIC. CYCLE 0: DV 3852; CYCLE 1: FV 2002; DV 7559; CYCLE 2 : FV 1250; DV 4962. THE DRAIN VOLUME OF 3852 IS 193% OVER THE EXPECTED DRAIN VOLUME. THE DRAIN VOLUME OF 7559 IS 378% OVER THE EXPECTED DRAIN VOLUME. THE REPORTED DRAIN VOLUME OF 4962 IS 248% OVER THE EXPECTED DRAIN VOLUME. THESE DRAIN VOLUMES RESULTED IN REPORTABLE DEVICE MALFUNCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353543 LIBERTY CYCLER SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1