BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 3950930 · Received July 14, 2014

    Report

    Report Number
    2937457-2014-01635
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 12, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, IT IS UNKNOWN HOW THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE POST MARKET SURVEILLANCE DEPARTMENT HAS REQUESTED MEDICAL RECORDS AND INVESTIGATIONS ARE PENDING. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED WHEN MEDICAL RECORDS ARE RECEIVED. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A NURSE REPORTED THAT A PATIENT WAS ADMITTED TO A HOSPITAL ON (B)(6) 2014, DUE TO HYPERTENSION. ACCORDING TO THE REPORTING NURSE, THE PATIENT DID NOT DIALYZE ON THE ADMISSION DATE, PRIOR TO THE HOSPITALIZATION. AS OF (B)(6) 2014, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL, THE COMPLAINT OF HYPERTENSION HAS RESOLVED, AND THE PATIENT CONTINUES TO USE CONTINUOUS CYCLER-ASSISTED PERITONEAL (CCPD) THERAPY WITHOUT ANY FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410159 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| O LIBERTY CYCLER CASSETTE| DELFLEX PD SOLUTION