BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 4110829 · Received September 10, 2014

    Report

    Report Number
    2937457-2014-02692
    Event Type
    Injury
    Date Received
    September 10, 2014
    Date of Event
    August 13, 2014
    Report Date
    August 13, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    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'S NURSE CALLED IN WITH AN OPERATIONAL QUESTION. DURING THIS CALL THE NURSE REPORTED THAT THE PATIENT HAD PERITONITIS AND THAT THE PATIENT WAS BEING ADMINISTERED ANTIBIOTICS. A FOLLOW UP CALL WAS MADE TO THE NURSE TO GATHER ADDITIONAL INFO. PER THE NURSE HE DID NOT REMEMBER THE PATIENT NAME OR ANY SPECIFIC INFO ABOUT THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559512 LIBERTY CYCLER FKX FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

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