BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 4162631 · Received October 7, 2014

    Report

    Report Number
    2937457-2014-02891
    Event Type
    Injury
    Date Received
    October 7, 2014
    Date of Event
    August 21, 2014
    Report Date
    September 9, 2014
    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

    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 PATIENT REPORTED THAT HE WAS DIAGNOSED WITH A RIGHT INGUINAL HERNIA ON 08/21/2014, DURING A PERITONEAL DIALYSIS CLINIC VISIT. THE PATIENT STATED HE HAD A SURGICAL CONSULT FOR A HERNIORRHAPHY ON (B)(6) 2014, BUT HAS NOT YET UNDERGONE THE SURGERY. NO PERITONEAL DIALYSIS TREATMENTS WERE MISSED AND THERE WAS NO REPORTABLE DEVICE MALFUNCTION. AS OF (B)(6) 2014, THE PATIENT CONTINUES TO USE CONTINUOUS CYCLER-ASSISTED PERITONEAL DIALYSIS (CCPD) THERAPY, AND THE PATIENT CONTINUES TO EXPERIENCE SIGNS AND SYMPTOMS OF A RIGHT INGUINAL HERNIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629986 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention LIBERTY CYCLER CASSETTE, DELFLEX PD SOLUTION