BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER CASSETTE

    MDR report key: 5130893 · Received October 2, 2015

    Report

    Report Number
    8030665-2015-00462
    Event Type
    Malfunction
    Date Received
    October 2, 2015
    Date of Event
    September 4, 2015
    Report Date
    September 5, 2015
    Manufacturer
    FRESENIUS MEDICAL CARE REYNOSA MANUFACTURING
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE PLANT INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION AND THE FAILURE MODE CANNOT BE CONFIRMED. HOWEVER, AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NONCONFORMANCES DURING THE MANUFACTURING PROCESS. IN ADDITION, THE BATCH RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) PT REPORTED A FLUID LEAK. DURING TREATMENT THE PT DISCOVERED FLUID LEAKING FROM THE CONNECTION BETWEEN HIS PT CONNECTOR AND HIS STAY SAFE EXTENDER. THE SET WAS RETAINED FOR ANALYSIS. DURING FOLLOW UP THE PT'S PD NURSE REPORTED THE PT DID NOT HAVE ANY SIGNS OF INFECTION. THE PT REPORTED THAT HIS EFFLUENT HAS REMAINED CLEAR. HE WAS NOT PRESCRIBED ANY ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656363 LIBERTY CYCLER CASSETTE FKX FRESENIUS MEDICAL CARE REYNOSA MANUFACTURING

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR