BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 3950915 · Received July 14, 2014

    Report

    Report Number
    2937457-2014-01634
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 12, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    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. THIS REPORTING NURSE WAS UNABLE TO PERFORM ADDITIONAL INFORMATION FOR THIS SAFETY REPORT.

    Description of Event or Problem · 1

    A NURSE REPORTS THAT THE PATIENT UNDERWENT A HERNIORRHAPHY ON (B)(6) 2014. NO PERITONEAL DIALYSIS TREATMENTS WERE MISSED AND THERE WERE NO REPORTABLE DEVICE MALFUNCTIONS. AS OF (B)(6) 2014, THE PATIENT'S SIGNS AND SYMPTOMS OF HERNIA HAVE RESOLVED AND THE PATIENT CONTINUES TO USE CONTINUOUS CYCLER ASSISTED PERITONEAL DIALYSIS (CCPD) THERAPY WITHOUT ANY FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410154 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

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