BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 4091236 · Received September 5, 2014

    Report

    Report Number
    2937457-2014-02647
    Event Type
    Injury
    Date Received
    September 5, 2014
    Date of Event
    August 7, 2014
    Report Date
    August 7, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 CLINICAL DEPARTMENT HAS REVIEWED MEDICAL RECORDS AND THE CLINICAL INVESTIGATION REVEALS THE FOLLOWING: BASED ON REVIEW OF THE 3 PAGES OF MEDICAL RECORDS AND INFORMATION OBTAINED FROM VERBAL REPORTS, THE DIAGNOSIS OF PERITONITIS IS CONFIRMED. THE PLANT INVESTIGATION IS PENDING. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A CONTINUOUS CYCLING PERITONEAL DIALYSIS (CCPD) PATIENT CALLED INTO TECHNICAL SUPPORT TO REPORT FLUID LEAKING FROM THE CYCLER DOOR AFTER THE COMPLETION OF HER TREATMENT. UPON FOLLOW UP WITH THE PATIENTS PERITONEAL DIALYSIS NURSE (PD RN), IT WAS REPORTED THE PATIENT WAS DIAGNOSED WITH PERITONITIS. ACCORDING TO THE PD RN, THE PATIENT REPORTED THAT SHE DEVELOPED A FEVER AND ABDOMINAL PAIN ON (B)(6) 2014, BUT DID NOT NOTIFY THE NURSE UNTIL (B)(6) 2014. A PD FLUID CULTURE WAS OBTAINED WHICH WAS POSITIVE FOR "3+ STAPHYLOCOCCUS SPECIES, COAGULASE NEGATIVE." THE PATIENT RECEIVED ANTIBIOTICS AND WAS FEELING WELL. SHE CONTINUES ON CCPD. THE CYCLER HAS BEEN RETURNED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545962 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention FRESENIUS PD SOLUTION| LIBERTY CYCLER SET