BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 4142649 · Received October 2, 2014

    Report

    Report Number
    2937457-2014-02807
    Event Type
    Injury
    Date Received
    October 2, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 3, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 STAFF AND COMPLETION OF THE PLANT'S INVESTIGATION. A REVIEW OF THE COMPLAINT DATABASE DID NOT REVEAL A HISTORY OF A RECENT FLUID LEAK.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) NURSE STATED A PATIENT HAD BEEN HOSPITALIZED BEGINNING ON (B)(6) 2014 AND BEGAN A COURSE OF VANCOMYCIN TO TREAT PERITONITIS. THE PATIENT WAS RELEASED FROM THE HOSPITAL AFTER A COUPLE DAYS OF MONITORING AND THE PATIENT DID NOT SUFFER ANY FURTHER COMPLICATIONS. THE NURSE STATED THE PATIENT DISCONNECTED WITHOUT USING ASEPTIC TECHNIQUE DURING A TREATMENT AND CONTRACTED PERITONITIS DUE TO TOUCH CONTAMINATION. MEDICAL RECORDS HAVE BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615279 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R LIBERTY CYCLER CASSETTE| PD SOLUTION