BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 3961631 · Received June 16, 2014

    Report

    Report Number
    2937457-2014-01644
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    June 30, 2014
    Report Date
    July 8, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL RECORDS WERE PROVIDED AND HAVE BEEN REVIEWED BY POST MARKET CLINICIAN STAFF AND PHYSICIAN. PATIENT IS A (B)(6) MALE WITH ESRD ON PD WHO WAS HOSPITALIZED FOR CLAIMS OF A CLOGGED PD CATHETER. BASED ON THE LIMITED MEDICAL RECORDS PROVIDED, IT APPEARS THAT ON (B)(6) 2014, THE PATIENT WAS DIAGNOSED WITH COAGULASE NEGATIVE STAPHYLOCOCCUS PERITONITIS. THE PATIENT REPORTED THAT HIS PD CATHETER WAS NOT WORKING PROPERLY FOR ABOUT A WEEK PRIOR TO THE DIAGNOSIS OF PERITONITIS. ON (B)(6) 2014, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR REMOVAL OF HIS PD CATHETER AND A TEMPORARY INSERTION OF A HEMODIALYSIS ACCESS CATHETER. PERITONITIS IS A KNOWN COMPLICATION OF PD AND IS USUALLY THE RESULT IN A BREACH IN ASPHERIC TECHNIQUE. DUE TO THE PATIENT'S HISTORY, IT IS UNLIKELY THAT THE LIBERTY CYCLER IS RELATED TO THIS EVENT OF PERITONITIS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF PLANT'S INVESTIGATION.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) NURSE REPORTED THAT A PATIENT WAS DIAGNOSED WITH CONFIRMED COAGULASE NEGATIVE STAPHYLOCOCCUS PERITONITIS. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2014. THE FOLLOWING IS BASED ON MEDICAL RECORDS PROVIDED BY THE PATIENT'S TREATMENT FACILITY. THE PATIENT HAD PROBLEMS WITH HIS PD CATHETER AND HAD NOT BEEN ABLE TO FILL PD FLUID AS IT APPEARED CLOGGED. THE CATHETER WAS REMOVED AND VASCULAR SURGERY WAS PERFORMED TO PROVIDE THE PATIENT ACCESS FOR HEMODIALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353311 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R MULTIVITAMIN| HYDRALAZINE| CALCITRIOL| PRAVASTATIN| LIBERTY CYCLER CASSETTE| DELFLEX PD SOLUTIONS| ALBUTREROL| LEVOFLOXACIN| GLIMEPIRIDE| CINACALCET| SERVERLAMER CARBONATE| AMLODIPINE| ENALAPRIL