BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 3213987 · Received July 3, 2013

    Report

    Report Number
    2937457-2013-00090
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    June 8, 2013
    Report Date
    June 8, 2013
    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 PLANT INVESTIGATION IS CURRENTLY ON-GOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION. SEE MDR #8030665-2013-00419 FOR INFORMATION RELATED TO THE CYCLER SET.

    Description of Event or Problem · 1

    THE PT'S WIFE REPORTED THAT DURING FILL 1 THE BLUE PIN DISCONNECTED AND STARTED TO LEAK. THE FOLLOWING MORNING THE PT WAS HAVING ABDOMINAL PAINS AND CRAMPING AND WAS TRANSPORTED TO THE HOSPITAL. THE PT WAS ADMINISTERED ANTIBIOTICS. WHILE IN THE HOSPITAL THE PT'S EFFLUENT WAS CHECKED AND REPORTED TO BE CLOUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303681 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA LIB

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R LIBERTY CYCLER SET