BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 3951798 · Received July 2, 2014

    Report

    Report Number
    2937457-2014-01481
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 3, 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 COMPLETION OF THE PLANT'S INVESTIGATION.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PATIENT CALLED IN AND REPORTED HIS EFFLUENT WAS CLOUDY. A FOLLOW UP CALL WAS MADE TO THE PATIENT'S PERITONEAL DIALYSIS NURSE. THE PATIENT WAS SEEN IN THE CLINIC ON (B)(6). CULTURES WERE DONE AND THE PATIENT WAS STARTED ON INTRAPERITONEAL VANCOMYCIN. THE PERITONEAL DIALYSIS NURSE STATED IT WAS A TOUCH CONTAMINATION, BUT SHE COULD NOT REMEMBER THE BACTERIA, AND DID NOT HAVE TIME TO CHECK WHILE ON THE PHONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385685 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention