BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN./EXT. DL

    MDR report key: 2243525 · Received August 19, 2011

    Report

    Report Number
    8030665-2011-00064
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    November 14, 2010
    Report Date
    August 19, 2011
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEW: THE DHR WAS REVIEWED AND THE FOLLOWING WAS FOUND: (B)(4). ALL THE APPLICABLE TESTS DURING THE IN-PROCESS AND FINAL INSPECTIONS WERE CONDUCTED IN ORDER TO ENSURE PRODUCT INTEGRITY AND WERE DOCUMENTED WITH ACCEPTABLE RESULTS ACCORDING TO APPLICABLE PROCEDURES. (B)(4). CONFIRMATION OF THE COMPLAINT: THE SAMPLE WAS NOT AVAILABLE FOR THE EVALUATION. THE COMPLAINT IS DEEMED AS NOT CONFIRMED. CORRECTIVE ACTION: THE SAMPLE WAS NOT AVAILABLE, THE COMPLAINT IS DEEMED AS UNCONFIRMED. UNFORTUNATELY WITHOUT THE SAMPLE IT IS NOT POSSIBLE TO PERFORM AN INVESTIGATION TO IMPLEMENT APPROPRIATE CORRECTIVE/PREVENTATIVE ACTIONS THAT LEAD TO AVOID THIS TYPE OF INCIDENT. FMC (B)(4) WILL CONTINUE MONITORING THIS TYPE OF INCIDENT PER CURRENT PROCEDURE.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PATIENT HAS REPORTED THAT AT THE END OF HIS TREATMENT, WHEN HE REMOVED THE CASSETTE, HE NOTICED A FLUID LEAK FROM THE CASSETTE AREA. THERE IS NO REPORT OF PATIENT ILL EFFECT. NO SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTY CYCLER SET, SINGLE CONN./EXT. DL LIBERTY CYCLER TUBING SET FKX REYNOSA MANUFACTURING NA 10LR08005

    Patients

    Seq Age Sex Outcome Treatment
    1 NA LIBERTY DIALYSIS MACHINE: