BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, DUAL PATIENT CONNECT

    MDR report key: 3202156 · Received June 28, 2013

    Report

    Report Number
    8030665-2013-00399
    Event Type
    Malfunction
    Date Received
    June 28, 2013
    Date of Event
    June 2, 2013
    Report Date
    June 2, 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 MANUFACTURER FOR PHYSICAL EVALUATION, AND THE LOT NUMBER WAS NOT ABLE TO BE OBTAINED TO DATE. DISTRIBUTION RECORDS WERE REVIEWED TO IDENTIFIED POTENTIAL LOTS OF THIS PRODUCT SHIPPED TO THE CUSTOMER OVER THE PAST ONE MONTHS. BATCH RECORDS FOR THE LOTS IDENTIFIED WERE REVIEWED AND CONFIRMED THERE WERE NO DEVIATIONS OR NONCONFORMANCE'S DURING THE MANUFACTURING PROCESS. IF THE SAMPLE IS RETURNED FOR EVALUATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE PT REPORTED SHE FOUND FLUID INSIDE THE CASSETTE DOOR AFTER TREATMENT. THE ORIGIN OF THE LEAK COULD NOT BE IDENTIFIED. THE PT WAS NOT PRESCRIBED ANTIBIOTICS AND HER EFFLUENT IS CLEAR. SAMPLE WAS INDICATED TO BE AVAILABLE, HOWEVER HAS NOT BEEN RETURNED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296609 LIBERTY CYCLER SET, DUAL PATIENT CONNECT FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1