BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, SINGLE PATIENT CONN

    MDR report key: 4060370 · Received August 8, 2014

    Report

    Report Number
    8030665-2014-00606
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 27, 2014
    Report Date
    July 8, 2014
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MFR FOR PHYSICAL EVAL AND THE FAILURE MODE CANNOT BE CONFIRMED. HOWEVER, AN INVESTIGATION OF THE DEVICE MFG RECORDS WAS CONDUCTED BY THE MFR. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES DURING THE MFG PROCESS. IN ADDITION, THE BATCH RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPEC.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) PT'S WIFE REPORTED THAT THE CYCLER ALARMED FOR AIR DETECTED IN THE CASSETTE DURING FILL 1. SHE WAS ADVISED TO RESET WITH NEW SUPPLIES. WHEN SHE OPENED THE CASSETTE DOOR, SHE DISCOVERED A FLUID LEAK. RATHER THAN CALL BACK IN FOR ASSISTANCE SHE DRIED IT UP AND SET UP FOR CONTINUING TREATMENT. THE PT COMPLETED TREATMENT THAT NIGHT. THE SET WAS DISCARDED. DURING F/U WITH THE PT'S WIFE SHE WAS ADVISED TO CONTACT THE PT'S PD NURSE ANYTIME THERE IS A LEAK. SHE REPORTED THAT HIS EFFLUENT WAS CLEAR AND ALL TREATMENTS HAD BEEN COMPLETED AS EXPECTED. DURING ADD'L F/U, THE PT'S PD NURSE REPORTED THAT HE HAS NOT HAD ANY SIGNS OF INFECTION AND NO ANTIBIOTICS WERE PRESCRIBED. NO ADVERSE EVENT REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473185 LIBERTY CYCLER SET, SINGLE PATIENT CONN FKX REYNOSA MANUFACTURING 13PR08069

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR LIBERTY CYCLER