BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 3082479 · Received April 25, 2013

    Report

    Report Number
    2937457-2013-00052
    Event Type
    Injury
    Date Received
    April 25, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 28, 2013
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL RECORDS WERE REQUESTED AND HAVE NOT BEEN RECEIVED BY THE MFR TO DATE. AT THE CONCLUSION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE RESULTS OF THE CLINICAL AND PLANT INVESTIGATIONS. THIS MEDWATCH REPORT IS ASSOCIATED WITH MDR #S 8030665-2013-00233, 8030665-2013-00234, 2937457-2013-00051.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PT HAS REPORTED THAT DIALYSIS SOLUTION WAS LEAKING OUT OF THE CASSETTE AND INTO THE CYCLER DURING TREATMENT. THE PERITONEAL DIALYSIS (PD) NURSE STATED THAT THE PT CALLED HER REPORTING THAT DURING TREATMENT, PT SAW A LEAK WHEN HE OPENED THE MACHINE CYCLER SET COMPARTMENT. THERE ARE TWO OCCURRENCES: (B)(6) 2013 AND THE ORDER OF THE EVENTS IS THE SAME. ON (B)(6) 2013 THE PT DID MANUAL EXCHANGES AND NO PROBLEMS OCCURRED. ON THE MORNING OF (B)(6) 2013 THE PT WENT TO THE CLINIC WITH A CLOUDY DRAIN BAG AND THE PT WAS PLACED ON ANTIBIOTICS PROPHYLACTICALLY. RN CALLED TO GET CYCLER REPLACED AND SHE TOLD THE PT TO NOT USE THE CYCLER SETS AND THE PT HAS. IN ADDITION, SHE TOLD THE PT TO KEEP THE SAMPLES. UPON F/U ON (B)(6) 2013, PT STATED THAT HE WAS DIAGNOSED WITH PERITONITIS. PT TOOK ANTIBIOTICS FOR 2 WEEKS AND NOW HIS EFFLUENT IS CLEAR, THE PT IS FINE, THE PERITONITIS HAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178349 LIBERTY CYCLER PERITONEAL DIALYSIS CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA LIB

    Patients

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