BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 4230630 · Received October 27, 2014

    Report

    Report Number
    2937457-2014-03042
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 29, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 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 DIAGNOSED WITH CANDIDA PARAPSILOSIS PERITONITIS, DURING A PERITONEAL DIALYSIS CLINIC VISIT, ON (B)(6) 2014, AND WAS STARTED ON AN UNKNOWN DOSE AND FREQUENCY OF VANCOMYCIN VIA INTRAPERITONEAL ROUTE AND AN UNKNOWN DOSE AND FREQUENCY OF DIFLUCAN VIA ORAL ROUTE. 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. ON AN UNKNOWN DATE IN (B)(6) 2014, THE PATIENT'S TREATMENT MODALITY WAS CHANGED FROM PERITONEAL DIALYSIS TO HEMODIALYSIS, DUE TO THE PERITONITIS; THE PERITONEAL DIALYSIS CATHETER WAS REMOVED AND A HEMODIALYSIS VASCULAR CATHETER WAS PLACED. NO DIALYSIS TREATMENTS WERE MISSED AND THERE WAS NO REPORTABLE DEVICE MALFUNCTION. AS OF (B)(6) 2014, THE PATIENT CONTINUES IN-CENTER HEMODIALYSIS THERAPY WITHOUT ANY FURTHER ISSUES. , THE PATIENT'S SIGNS AND SYMPTOMS OF PERITONITIS HAVE RESOLVED, AND THE PATIENT HAS DISCONTINUED TAKING VANCOMYCIN AND DIFLUCAN. THERE IS NO ALLEGATION AGAINST ANY FRESENIUS PRODUCT IN RELATION TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681026 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other DELFLEX PD SOLUTION| LIBERTY CYCLER CASSETTE