BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN./EXT. DL

    MDR report key: 3982840 · Received June 25, 2014

    Report

    Report Number
    8030665-2014-00540
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    June 7, 2014
    Report Date
    June 7, 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 FAILURE MODE CANNOT BE CONFIRMED. HOWEVER, AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES DURING THE MANUFACTURING PROCESS. IN ADDITION, THE BATCH RECORD REVIEW CONFIRMED THE LABELING MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PATIENT REPORTED THAT DIALYSIS SOLUTION WAS LEAKED OUT OF THE CASSETTE AND INTO THE CYCLER. PATIENT STATED THAT THERE WAS FLUID LEAKING INSIDE THE CASSETTE DOOR WHEN SHE REMOVED THE CASSETTE AFTER COMPLETING TREATMENT. NURSE STATED THAT THE PATIENT WAS FINE AND DID NOT REQUIRE ANY MEDICAL INTERVENTION. SAMPLE HAS NOT BEEN RETURNED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370533 LIBERTY CYCLER SET, SINGLE CONN./EXT. DL FKX REYNOSA MANUFACTURING 13JR08122

    Patients

    Seq Age Sex Outcome Treatment
    1 PD SOLUTIONS| LIBERTY DIALYSIS CYCLER