BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 4914820 · Received July 13, 2015

    Report

    Report Number
    2937457-2015-01262
    Event Type
    Injury
    Date Received
    July 13, 2015
    Date of Event
    June 11, 2015
    Report Date
    June 15, 2015
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION AND THE FAILURE MODE CANNOT BE CONFIRMED. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES DURING THE MANUFACTURING PROCESS. IN ADDITION, THE HISTORY RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE CLINICAL REVIEW OF ANY AVAILABLE MEDICAL RECORDS.

    Description of Event or Problem · 1

    DURING A FOLLOW UP CALL FOR AN UNRELATED EVENT ON (B)(6) 2015, THE PERITONEAL DIALYSIS (PD) NURSE STATED THAT THE PT WAS EXPERIENCING SHORTNESS OF BREATH AND HOSPITALIZED ON (B)(6) 2015. THE PT WAS STILL IN THE HOSPITAL ON (B)(6) 2015. MEDICAL RECORDS TO BE PROVIDED UPON DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451976 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R LIBERTY CYCLER CASSETTE| PERITONEAL DIALYSIS DELFLEX SOLUTION