BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 3810651 · Received April 30, 2014

    Report

    Report Number
    2937457-2014-00733
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 29, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON FINAL REVIEW OF MEDICAL RECORDS BY POST MARKET CLINICAL PHYSICIAN AND COMPLETION OF THE PLANT'S INVESTIGATION. RELATED MDRS: 8030665-2014-00339 AND 1713747-2014-99954.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) PATIENT REPORTED AIR BUBBLES GOING INTO HIS MACHINE AND LATER FEELING FULL. THE PATIENT WAS TREATED WITH PROPHYLACTIC ANTIBIOTICS. THE PATIENT WENT ON TO DEVELOP CONFIRMED PROVIDENCIA RETTGERI PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258933 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention LIBERTY CYCLER CASSETTE, DELFLEX PD SOLUTION