BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIBERTY CYCLER

    MDR report key: 4761750 · Received May 8, 2015

    Report

    Report Number
    2937457-2015-00847
    Event Type
    Death
    Date Received
    May 8, 2015
    Date of Event
    March 31, 2015
    Report Date
    April 8, 2015
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION AND DETERMINED TO BE FUNCTIONING ACCORDING TO PRODUCT SPECIFICATIONS. THERE WERE NO INDICATIONS OF DRIED FLUID WITHIN THE CASSETTE COMPARTMENT. NO BURS OR SHARPS IN THE AREA THAT MAY HAVE PUNCTURED A CASSETTE MEMBRANE. THERE WAS VISUAL EVIDENCE OF DRIED FLUID UNDER PUMP A AND B MUSHROOM HEAD AND WITHIN THE RECESS OF THE BOTTOM COVER ADJACENT TO THE PUMP. THE SYSTEM AIR LEAK AND VALVE ACTUATION TESTS PASSED. THE LOAD CELL AND VERIFICATION WERE WITHIN TOLERANCE. THE PATIENT SENSOR CALIBRATION CHECK PASSED. THERE WERE NO INTERNAL INSPECTION DISCREPANCIES. THE MUSHROOM HEAD CHECK PASSED. A BATCH RECORD REVIEW WAS CONDUCTED AND CONFIRMED THERE WERE NO DEVIATION OR NON-CONFORMANCES DURING THE MANUFACTURING PROCESS. PRODUCT LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A NURSE REPORTED THAT A PATIENT WAS ADMITTED TO A HOSPITAL ON (B)(6) 2015, DUE TO FLUID VOLUME OVERLOAD, SEPTICEMIA, AND AN EXACERBATION OF CONGESTIVE HEART FAILURE. ON (B)(6) 2015, PERITONEAL EFFLUENT WAS CULTURED AND THE PATIENT WAS DIAGNOSED WITH FUNGAL PERITONITIS, SPECIES UNKNOWN. THIS NURSE STATED THAT THE EPISODE OF PERITONITIS WAS DUE TO TOUCH CONTAMINATION, WHERE THE PATIENT DID NOT PRACTICE ASEPTIC TECHNIQUE. ON (B)(6) 2015, THE PATIENT EXPIRED. MEDICAL RECORDS WERE REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304659 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death| H| O LIBERTY CYCLER CASSETTE| DELFLEX PD SOLUTION