BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, CINGLE CON/EXT DL

    MDR report key: 4180393 · Received October 15, 2014

    Report

    Report Number
    8030665-2014-00799
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 14, 2014
    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

    THE ACTUAL DEVICE WAS RETURNED TO THE MFR FOR A PHYSICAL EVALUATION AND THE COMPLAINT IS CONFIRMED. VISUAL AND PHOTOGRAPHIC INSPECTION FOUND A TEAR IN THE MEMBRANE OF THE CASSETTE. OPTICAL MICROSCOPY SHOWED A SINGLE SCRATCH BREACHED THE MEMBRANE. THERE WAS NO DAMAGE TO THE HARD PLASTIC OF THE CASSETTE. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MFR. 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 SPECIFICATIONS.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) PT REPORTED A FLUID LEAK. THE FLUID WAS LEAKING FROM THE CASSETTE DOOR. THE PT WAS ADVISED TO DISCONTINUE USING THE CYCLER AND TO CONTACT THE PD NURSE. THE SET WAS RETAINED AND MADE AVAILABLE FOR EVALUATION. DURING FOLLOW UP, THE PT'S PD NURSE REPORTED THAT THE PT DID NOT HAVE ANY SIGNS OF INFECTION. HE WAS TREATED WITH A SINGLE DOSE OF PROPHYLACTIC ANTIBIOTICS VANCOMYCIN AND GENTAMICIN. NO ADVERSE EVENT REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654094 LIBERTY CYCLER SET, CINGLE CON/EXT DL FKX FRESENIUS MEDICAL CARE REYNOSA MANUFACTURING 13SR08005

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR LIBERTY CYCLER