BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 3950916 · Received July 14, 2014

    Report

    Report Number
    2937457-2014-01632
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    May 20, 2014
    Report Date
    June 11, 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 ADMITTED TO A HOSPITAL ON (B)(6) 2014, DUE TO ESCHERICHIA COLI PERITONITIS. ON (B)(6) 2014, THE PATIENT'S PERITONEAL DIALYSIS CATHETER WAS REMOVED DUE TO THE PERITONITIS. THIS NURSE STATED THAT THE EPISODE OF PERITONITIS WAS DUE TO TOUCH CONTAMINATION, WHERE THE PATIENT DID NOT PRACTICE ASEPTIC TECHNIQUE DURING TREATMENT. THE PATIENT DID NOT WASH THEIR HANDS AND DID NOT WEAR A MASK. THE PATIENT RECEIVED AN UNKNOWN DRUG NAME, DOSE, AND ROUTE OF ANTIBIOTICS FOR THE PERITONITIS. ON AN UNKNOWN DATE AFTER BEING ADMITTED, THE PATIENT'S TREATMENT MODALITY WAS CHANGED FROM PERITONEAL DIALYSIS TO HEMODIALYSIS. ON (B)(6) 2014, THE PATIENT DISCONTINUED HEMODIALYSIS THERAPY AND CHANGED MEDICAL TREATMENT TO COMFORT MEASURES ONLY. AS OF (B)(6) 2014, THE PATIENT CONTINUES TO BE HOSPITALIZED, AND THE PATIENT'S SIGNS AND SYMPTOMS OF PERITONITIS HAVE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410046 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R LIBERTY CYCLER CASSETTE| DELFLEX PD SOLUTION