BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET

    MDR report key: 3963359 · Received June 19, 2014

    Report

    Report Number
    8030665-2014-00496
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 11, 2014
    Report Date
    May 21, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    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 IDENTIFY POTENTIAL LOTS OF THIS PRODUCT SHIPPED TO THE CUSTOMER OVER THE PAST 3 MONTHS. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES DURING THE MANUFACTURING PROCESS. IN ADDITION, THE BATCH RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    DURING FOLLOW UP WITH THE HOME THERAPIES MANAGER FOR A RELATED ISSUE, IT WAS REPORTED THE PATIENT FOUND "WETNESS" INSIDE THE CYCLER WHEN SHE REMOVED THE CASSETTE AFTER HER TREATMENT. THE PATIENT WAS GIVEN PROPHYLACTIC ANTIBIOTICS. HER EFFLUENT HAS REMAINED CLEAR AND SHE IS CONTINUING ON PERITONEAL DIALYSIS WITH THE CYCLER. THE SAMPLE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359173 LIBERTY CYCLER SET FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 FRESENIUS PD SOLUTION| LIBERTY CYCLER