BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN/EXT DL

    MDR report key: 4230773 · Received October 24, 2014

    Report

    Report Number
    8030665-2014-00824
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 25, 2014
    Manufacturer
    FRESENIUS MED CARE REYNOSA MFG
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR PHYSICAL EVAL AND THE FAILURE MODE CANNOT BE CONFIRMED. AN INVESTIGATION OF THE DEVICE MFG RECORDS WAS CONDUCTED BY THE MFR. THERE WERE NO DEVIATIONS OR NONCONFORMITIES DURING THE MFG PROCESS. IN ADDITION, THE BATCH RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) PT REPORTED HIS CYCLER ALARMED FOR AIR DETECTED IN THE CASSETTE DURING FILL 2. HE WAS UNABLE TO CLEAR THE ERROR AND WAS ADVISED TO SET UP WITH NEW SUPPLIES. WHEN HE OPENED THE CASSETTE DOOR HE FOUND FLUID LEAKING. HE MANUALLY COMPLETED TREATMENT AND CONTACTED HIS PD NURSE. THE SET WAS NOT MADE AVAILABLE FOR EVAL. DURING FOLLOW UP THE PT'S PD NURSE REPORTED THAT THE PT DID NOT HAVE ANY SIGNS OF INFECTION. HIS EFFLUENT REMAINED CLEAR. HE WAS NOT PRESCRIBED ANY ANTIBIOTICS. NO ADVERSE EVENT REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678343 LIBERTY CYCLER SET, SINGLE CONN/EXT DL FKX FRESENIUS MED CARE REYNOSA MFG 14ER08085

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR LIBERTY CYCLER