BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FRESENIUS LIBERTY CYCLER

    MDR report key: 4110278 · Received September 10, 2014

    Report

    Report Number
    2937457-2014-02674
    Event Type
    Malfunction
    Date Received
    September 10, 2014
    Date of Event
    June 9, 2011
    Report Date
    June 9, 2011
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS DRIED FLUID INSIDE THE CASSETTE DOOR AND INSIDE THE PNEUMATIC LINES BETWEEN THE PUMP BODY AND THE HYDROPHOBIC FILTERS. THE CYCLER PASSED A MUSHROOM HEAD CHECK. THERE WERE NO ABRASIONS ON THE MUSHROOM HEADS. PER THE MC PHARMACOVIGILANCE PHYSICIAN: NO TREATMENTS WERE MISSED, MANUAL EXCHANGES WERE COMPLETED WHILE WAITING FOR THE REPLACEMENT CYCLER. PT DID NOT DEVELOP PERITONITIS OR OTHER COMPLICATIONS. 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 21 MARCH 2011 TO 11 MARCH 2013.

    Description of Event or Problem · 1

    PERITONEAL DIALYSIS NURSE STATED THAT WHEN IS PT COMPLETED TREATMENT, HE DISCONNECTED FROM THE CYCLER AND NOTICED FLUID LEAKING FROM THE CASSETTE. PT CONTACTED NURSE. CYCLER WAS RETURNED WITH CASSETTE AND REPLACED. MANUAL EXCHANGES WERE COMPLETED, NO MISSED TREATMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559870 FRESENIUS LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA LIB

    Patients

    Seq Age Sex Outcome Treatment
    1