BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 4223639 · Received October 31, 2014

    Report

    Report Number
    2937457-2014-03057
    Event Type
    Injury
    Date Received
    October 31, 2014
    Date of Event
    August 4, 2014
    Report Date
    September 30, 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 NURSE REPORTED THAT A PATIENT WAS HOSPITALIZED ON (B)(6) 2014 DUE TO PERITONITIS. THIS NURSE STATED THAT THE EPISODE OF PERITONITIS WAS DUE TO TOUCH CONTAMINATION, WHERE THE PATIENT DID NOT PRACTICE ASEPTIC TECHNIQUE AND BROKE THE STERILE FIELD DURING TREATMENT: THE PATIENT DID NOT WASH THEIR HANDS AND DID NOT DO A MASK. NO DIALYSIS TREATMENTS WERE MISSED AND THERE WAS NO REPORTABLE MALFUNCTION. ON AN UNKNOWN DATE AFTER BEING ADMITTED, THE PATIENT'S MODALITY WAS CHANGED FROM PERITONEAL DIALYSIS TO HEMODIALYSIS, AND THE PATIENT'S PERITONEAL DIALYSIS CATHETER WAS REMOVED. AS OF (B)(6) 2014, THE PATIENT CONTINUES TO BE HOSPITALIZED AND CONTINUES HEMODIALYSIS THERAPY. AS OF (B)(6) 2014, IT IS UNKNOWN IF THE PATIENT'S SIGNS AND OR SYMPTOMS OF PERITONITIS HAVE RESOLVED. LIMITED INFORMATION WAS PROVIDED FOR THIS SAFETY REPORT.,

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700241 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R