BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 3896222 · Received June 13, 2014

    Report

    Report Number
    2937457-2014-01041
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 30, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF PLANT'S INVESTIGATION.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) REPORTED A PT BROKE ASEPTIC TECHNIQUE AND SWAPPED TREATMENT BAGS DURING TREATMENT. A CULTURE REVEALED TOUCH CONTAMINATION PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351193 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LIBERTY CYLER CASSETTE| DELFLEX PD SOLUTIONS