BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 3934432 · Received June 27, 2014

    Report

    Report Number
    2937457-2014-01362
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    May 30, 2014
    Report Date
    May 30, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    KO43363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON FINAL REVIEW OF MEDICAL RECORDS BY POST MARKET CLINICAL AND COMPLETION OF THE PLANT'S INVESTIGATION. THE RELATED MDRS # 2937457-2014-01362 AND 1713747-2014-99993.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) NURSE REPORTED THAT THE PATIENT CONTRACTED PERITONITIS. THE PATIENT PRESENTED TO THE CLINIC ON (B)(6) 2014. THE PATIENT WAS TREATED WITH CEFTAZIDIME VIA IP. THE PATIENT PRODUCED A POSITIVE CULTURE RESULT. THE PATIENT WAS NOT HOSPITALIZED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375766 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention LIBERTY CYCLER CASSETTE| DELFLEX SOLUTION,