BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN/EXT DL

    MDR report key: 3202182 · Received June 28, 2013

    Report

    Report Number
    8030665-2013-00401
    Event Type
    Malfunction
    Date Received
    June 28, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 3, 2013
    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

    THE DEVICE WAS NOT RETURNED TO THE MFR FOR PHYSICAL EVALUATION, AND THE LOT NUMBER WAS NOT ABLE TO BE OBTAINED TO DATE. DISTRIBUTION RECORDS WERE REVIEWED TO IDENTIFY POTENTIAL LOTS OF THIS PRODUCT SHIPPED TO THE CUSTOMER OVER THE PAST ONE MONTH. BATCH RECORDS FOR THE LOTS IDENTIFIED WERE REVIEWED AND CONFIRMED THERE WAS NO DEVIATIONS OR NONCONFORMANCE DURING THE MFG PROCESS.

    Description of Event or Problem · 1

    THE PT REPORTED THE SOLUTION BAG LINES ARE BLOCKED IN DWELL 3 OF 4 AND FOUND THAT THE TUBING SET WAS LEAKING. THE PT REPORTED THE EVENT TOOK PLACE DURING TREATMENT WHEN HE ENCOUNTERED AN AIR DETECTED IN CASSETTE ALARM AND SAW A LEAK COMING FROM THE CLOSED CYCLER DOOR. THE PT SUFFERED NO ADVERSE EVENT AS A RESULT. SAMPLE NOT AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295063 LIBERTY CYCLER SET, SINGLE CONN/EXT DL FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 LIBERTY CYCLER