BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, DUAL PT CONNECT

    MDR report key: 2243493 · Received August 19, 2011

    Report

    Report Number
    8030665-2011-00071
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    December 6, 2010
    Report Date
    August 19, 2011
    Manufacturer
    REYNOSA MFG
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEW: THE DHR OF THIS PRODUCT 050-87212, LOT #10HR08038 WAS REVIEWED AND THE FOLLOWING HIGHLIGHTS WERE FOUND: THE PRODUCT DID NOT HAVE ANY NCR. NO DEVIATION WAS DOCUMENTED DURING THE MFG PROCESS. 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. NO REWORDS/RE-INSPECTIONS WERE PERFORMED TO THIS FINISHED GOODS LOT OF 10HR0838. SAMPLE ANALYSIS. NO SAMPLE WAS RECEIVED FOR EVAL. CONCLUSION: THE SAMPLE WAS NOT RECEIVED AND THE COMPLAINT IS DEEMED AS UNCONFIRMED. UNFORTUNATELY, WITHOUT THE COMPLAINT SAMPLE, IT IS NOT POSSIBLE TO PERFORM AN INVESTIGATION TO IMPLEMENT APPROPRIATE CORRECTIVE/PREVENTATIVE ACTIONS THAT LEAD TO AVOID THIS TYPE OF INCIDENT. FMC WILL CONTINUE TO MONITOR AND TREND PER CURRENT PROCEDURE.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PT REPORTED THAT THE MACHINE ALARMED LEAK. THE PT NOTICED A HOLE IN THE CASSETTE. THE SAMPLE WAS SAVED, HOWEVER, WAS NOT FORWARDED ON OR RECEIVED FOR EVAL. THERE IS NO INFO OF ANY ILL EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTY CYCLER SET, DUAL PT CONNECT PERITONEAL DIALYSIS TUBING TREATMENT SET FKX REYNOSA MFG NA 10HR08038

    Patients

    Seq Age Sex Outcome Treatment
    1 NA LIBERTY DIALYSIS MACHINE