BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER SET, DUAL PATIENT CONNECT

    MDR report key: 3761029 · Received April 11, 2014

    Report

    Report Number
    8030665-2014-00287
    Event Type
    Injury
    Date Received
    April 11, 2014
    Date of Event
    March 14, 2014
    Report Date
    March 14, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A SERIOUSLY INJURY HAS OCCURRED TO A PERITONEAL DIALYSIS PATIENT FOLLOWING TREATMENT WITH OUR PRODUCT. DUE TO A LACK OF INFORMATION A MDR'S WILL BE FILED AGAINST THE TUBING WHILE UNDERGOING REVIEW BY POST MARKET CLINICAL DEPARTMENT AND MANUFACTURING PLANT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE PLANT'S INVESTIGATION.

    Description of Event or Problem · 1

    A REGISTERED NURSE CALLED TO REPORT ISSUES WITH DISCONNECTING A PATIENT FROM PERITONEAL DIALYSIS (PD) THERAPY. THE NURSE WAS UNABLE TO CLOSE OFF THE PATIENT'S CATHETER LINE AS THE CAP WOULD NOT FIT. DURING THE COURSE OF THE CALL, THE NURSE REPORTED THE PATIENT WAS CURRENTLY IN THE HOSPITAL DUE TO A CEREBROVASCULAR EVENT. ADDITIONAL DETAILS SURROUNDING THE PATIENT'S COURSE OF CARE WAS UNAVAILABLE AT THE TIME OF THE CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220670 LIBERTY CYCLER SET, DUAL PATIENT CONNECT FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R LIBERTY CYCLER