BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, DUAL PATIENT CONNECT

    MDR report key: 3833019 · Received March 25, 2014

    Report

    Report Number
    8030665-2014-00243
    Event Type
    Malfunction
    Date Received
    March 25, 2014
    Date of Event
    February 28, 2014
    Report Date
    February 28, 2014
    Manufacturer
    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 DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION, AND THE LOT NUMBER WAS NOT ABLE TO BE OBTAINED TO DATE. DISTRIBUTION RECORDS WERE REVIEWED TO IDENTIFY POTENTIAL LOTS OF THIS PRODUCT SHIPPED TO THE CUSTOMER OVER THE PAST 3 MONTHS. BATCH RECORDS FOR THE LOTS IDENTIFIED WERE REVIEWED AND CONFIRMED THERE WERE NO DEVIATIONS OR NON-CONFORMANCES DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) PATIENT REPORTED FINDING FLUID UNDER HER CYCLER FOLLOWING TREATMENT. THE CYCLER ALARMED FOR "BALLOON VALVE LEAK" DURING THIS TREATMENT. THE PATIENT WAS ADVISED TO DISCONTINUE USING THE CYCLER AND TO CONTACT HER PD NURSE. SHE DISCARDED THE SET. DURING FOLLOW UP, THE PATIENT REPORTED THAT HER EFFLUENT HAS REMAINED CLEAR. THERE WERE NO SIGNS OF INFECTION AND NO PROPHYLACTIC ANTIBIOTICS WERE ADMINISTERED. NO ADVERSE EVENT REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173753 LIBERTY CYCLER SET, DUAL PATIENT CONNECT FKX REYNOSA MANUFACTURING

    Patients

    Seq Age Sex Outcome Treatment
    1 LIBERTY CYCLER