BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER SET, DUAL PATIENT CONNECT

    MDR report key: 3934405 · Received June 27, 2014

    Report

    Report Number
    8030665-2014-00513
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    May 27, 2014
    Report Date
    June 4, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    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 INVESTIGATION ARE PENDING. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON FINAL REVIEW OF MEDICAL RECORDS BY THE POST MARKET CLINICAL AND COMPLETION OF THE PLANT INVESTIGATION. THE RELATED MDRS # 2937457-2014-01361, 8030665-2014-00513 AND 1713747-2014-99992.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) NURSE REPORTED DURING FOLLOW UP THAT THE PATIENT WAS DIAGNOSED WITH COAGULASE-NEGATIVE STAPHYLOCOCCI PERITONITIS ON (B)(6) 2014 AND ADMITTED ON (B)(6) 2014. THERE HAD BEEN NO REPORTED FLUID LEAKS DURING TREATMENT PRIOR TO THE INFECTION. THE NURSE INDICATED THE PATIENT PRACTICED ASEPTIC TECHNIQUE DURING TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375761 LIBERTY CYCLER SET, DUAL PATIENT CONNECT FKX FRESENIUS MEDICAL CARE NORTH AMERICA 14BR08039

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R LIBERTY CYCLER,| DELFLEX PD SOLUTIONS