BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 3874861 · Received June 2, 2014

    Report

    Report Number
    2937457-2014-00914
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    June 1, 2013
    Report Date
    May 1, 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 INFO PROVIDED, IT IS UNK HOW THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON FINAL REVIEW OF MEDICAL RECORDS BY THE POST MARKET CLINICAL PHYSICIAN AND COMPLETION OF THE PLANT'S INVESTIGATION.

    Description of Event or Problem · 1

    A REVIEW OF THE MEDICAL RECORDS REVEALED THAT THE PT EXPERIENCED REOCCURRING UNRESOLVED PERITONITIS DUE TO POOR ASEPTIC TECHNIQUE. (B)(6) 2013: COAGULASE NEGATIVE STAPHYLOCOCCUS PERITONITIS. (B)(6) 2013: (B)(6) INFECTIONS OF PD CATHETER EXIT SITE. (B)(6) 2013: STAPHYLOCOCCUS HAEMOLYTICUS PERITONITIS. (B)(6) 2013: CLOSTRIDIUM - DIFFICILE COLITIS EXACERBATION. (B)(6) 2013: STAPHYLOCOCCUS EPIDERMIS PERITONITIS. (B)(6) 2013: (B)(6) INFECTION OF PD CATHETER EXIT SITE. (B)(6) 2013: COAGULASE NEGATIVE STAPHYLOCOCCUS PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321053 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| O| R DELFLEX PD SOLUTION| LIBERTY CYCLER CASSETTE