BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, DUAL PATIENT CONNECT

    MDR report key: 2241671 · Received August 19, 2011

    Report

    Report Number
    8030665-2011-00047
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    December 12, 2010
    Report Date
    August 17, 2011
    Manufacturer
    REYNOSA MFG.
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEW: THE DHR OF THIS PRODUCT 050-87212 LOT# 10JR08064 WAS REVIEWED AND THE FOLLOWING HIGHLIGHTS WERE FOUND: THE ASSEMBLY OF THE PRODUCT DID NOT HAVE ANY NCR OR DEVIATIONS 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. LIBERTY CASSETTE LOT NUMBERS: 10JR07173 AND 10JR07174 USED TO PRODUCE THIS PRODUCT CODE AND LOT NUMBER OF 10JR08064 AND WERE REVIEWED. THE COMPLAINT DATABASE WAS CONSIDERED AND NO OTHER COMPLAINT HAS BEEN RECEIVED WITH THE SAME FAILURE DESCRIPTION FOR THIS LOT. SAMPLE ANALYSIS: FMC RECEIVED THE ACTUAL AND 4 COMPANIONS FOR EVAL FROM THIS CODE AND LOT. A VISUAL EXAM/ANALYSIS WAS PERFORMED TO THE SAMPLES AND NO DAMAGE/DEFECTS WERE FOUND. A FUNCTIONAL TEST WAS PERFORMED WITH THE LIBERTY CYCLER AND THE ACTUAL SAMPLE AND COMPANIONS DID NOT SHOW ANY PROBLEMS AND THE TREATMENTS WERE COMPLETED SUCCESSFULLY WITHOUT ANY LEAKS. CONCLUSION: THE ACTUAL AND COMPANION SAMPLES DID NOT SHOW ANY DEFECTS. THE COMPLAINT IS DEEMED AS UNCONFIRMED. CONCLUSION: SINCE THE COMPLAINT WAS NOT CONFIRMED NO CORRECTIVE ACTION IS DOCUMENTED AT THIS TIME. FMC NA WILL CONTINUE TO MONITOR AND TREND PER PROCEDURE.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PT HAS REPORTED A LEAK AT THE CASSETTE. A SAMPLE IS AVAILABLE FOR EVAL. THERE IS NO INFO OF ANY ILL EFFECT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTY CYCLER SET, DUAL PATIENT CONNECT PERITONEAL DIALYSIS TUBING SET FKX REYNOSA MFG. NA 10JR08064

    Patients

    Seq Age Sex Outcome Treatment
    1 NA LIBERTY DIALYSIS MACHINE