BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 3980037 · Received June 25, 2014

    Report

    Report Number
    2937457-2014-01607
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 6, 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 ABDOMINAL PAIN AND CLOUDY EFFLUENT. PERITONITIS WAS RULED OUT WITH NEGATIVE PERITONEAL EFFLUENT CULTURES DRAWN ON (B)(6) 2014. THE PATIENT DID NOT RECEIVE PROPHYLACTIC ANTIBIOTICS VIA INTRAPERITONEAL ROUTE DURING THE ADMISSION. ON AN UNKNOWN DATE DURING THE ADMISSION, THE PATIENT WAS DIAGNOSED WITH A PSEUDOMONAS URINARY TRACT INFECTION, AND WAS TREATED WITH AN UNKNOWN DOSE AND FREQUENCY OF FLAGYL AND LEVOQUIN VIA ORAL ROUTE. NO PERITONEAL DIALYSIS TREATMENTS WERE MISSED AND THERE WAS NO REPORTABLE DEVICE MALFUNCTION. ON AN UNKNOWN DATE IN (B)(6) 2014, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. AS OF (B)(6) 2014, THE PATIENT CONTINUES TO USE CONTINUOUS CYCLER-ASSISTED PERITONEAL DIALYSIS (CCPD) THERAPY WITHOUT ANY FURTHER ISSUES, AND THE PATIENT'S COMPLAINT OF ABDOMINAL PAIN, CLOUDY EFFLUENT, AND URINARY TRACT INFECTION HAVE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371438 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| O| R DELFLEX PD SOLUTION| LIBERTY CYCLER CASSETTE