BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FRESENIUS LIBERTY CYCLER

    MDR report key: 4110273 · Received September 10, 2014

    Report

    Report Number
    2937457-2014-02670
    Event Type
    Malfunction
    Date Received
    September 10, 2014
    Date of Event
    October 4, 2012
    Report Date
    October 4, 2012
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LIBERTY CYCLER WAS RETURNED FOR EVAL, NO NON-CONFORMITIES WERE FOUND. THE UNIT PASSED ALL TESTS DURING SIMULATED TREATMENT TESTING AND MET SPECIFICATIONS. A BATCH RECORD REVIEW WAS CONDUCTED AND CONFIRMED THERE WERE NO DEVIATIONS OR NON-CONFORMANCES. PRODUCT LABELING, MATERIAL, AND PROCESS CONTROLS WERE FOUND TO BE WITHIN SPECIFICATIONS. THE EVAL INDICATES THE PT DID NOT DEVELOP ANY INFECTION OR COMPLICATION. THERE WAS NO REPORTED ILL EFFECT FROM THIS INCIDENT AND NO MEDICAL INTERVENTION GIVEN. THIS IS A RETROSPECTIVE MDR BEING SUBMITTED BY FRESENIUS MEDICAL CARE AS A REMEDIATION ACTION COMMITTED TO FDA REGARDING ALL POTENTIAL ADVERSE EVENTS RECEIVED BETWEEN (B)(4) 2011 TO (B)(4) 2013.

    Description of Event or Problem · 1

    PT/USER OF THE FMC DEVICE CALLED TECH SUPPORT STATING THERE WAS A FLUID LEAK, HE REMOVED THE CASSETTE AND NOTICED THE FLUID LEAKING FROM THE CASSETTE, THEN NOTICED A PUDDLE OF FLUID UNDERNEATH THE CYCLER. PT WAS IMMEDIATELY ADVISED TO DISCONTINUE USE OF CYCLER AND INFORMED HIM CYCLER WILL BE REPLACED. DURING A FOLLOW UP PHONE CALL THE PT THERE WAS NO ILL EFFECT FROM THE FLUID LEAK INCIDENT, NO SIGN OF INFECTION AND NO MEDICAL INTERVENTION SOUGHT. PT HAS RECEIVED REPLACEMENT CYCLER AND CONTINUES CCPD WITH NO PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559523 FRESENIUS LIBERTY CYCLER FRESENIUS LIBERTY CYCLER FKX FKX FRESENIUS MEDICAL CARE NORTH AMERICA LIB

    Patients

    Seq Age Sex Outcome Treatment
    1