BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, DUAL PATIENT CONNECT

    MDR report key: 2241672 · Received August 19, 2011

    Report

    Report Number
    8030665-2011-00049
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    December 20, 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
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEW: THE DHR OF THIS PRODUCT 050-87212 LOT# 10HR08094 WAS REVIEWED AND THE FOLLOWING HIGHLIGHTS WERE FOUND: THE PRODUCT DID NOT HAVE ANY NCRS 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 NUMBER: 10HR07163 USED TO PRODUCE CODE (B)(4) LOT NUMBER 10HR08094 WAS REVIEWED AND NO ISSUES WERE REPORTED DURING THE MFG PROCESS. THE COMPLAINT DATABASE WAS CONSULTED AND NO OTHER COMPLAINT HAS BEEN RECEIVED WITH THE SAME FAILURE DESCRIPTION FOR THIS LOT. SAMPLE ANALYSIS: (B)(4) RECEIVED 3 ACTUAL SAMPLES AND 1 COMPANION SAMPLE FROM THIS CODE AND LOT. A VISUAL ANALYSIS WAS PERFORMED TO THE SAMPLES AND NO DAMAGE OR DEFECT WAS FOUND. A FUNCTIONAL TEST WITH THE (B)(4) WAS PERFORMED TO THE ACTUAL AND COMPANION SAMPLES WITH THE FOLLOWING RESULTS: THE CASSETTE COMPANION AND ACTUAL SAMPLES DID NOT SHOW ANY PROBLEMS AND THE TREATMENTS WERE COMPLETED SUCCESSFULLY WITHOUT ANY LEAKS. CONCLUSION: THE REPORTED COMPLAINT IS UNCONFIRMED AS THE SAMPLES DID NOT SHOW ANY DEFECTS. CONCLUSION: SINCE THE COMPLAINT WAS NOT CONFIRMED, NO CORRECTIVE ACTION IS DOCUMENTED AT THIS TIME. FMC (B)(4) WILL CONTINUE TO MONITOR AND TREND PER CURRENT PROCEDURE.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PT HAS REPORTED THAT THE CASSETTE WAS LEAKING. THE PT REPORTED THAT THE LEAK OCCURRED WHILE SHE WAS SETTING UP FOR HER TREATMENT. A SAMPLE IS AVAILABLE FOR AN EVAL. NO REPORT OF ILL EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTY CYCLER SET, DUAL PATIENT CONNECT PERITONEAL DIALYSIS TUBING TREATMENT SET FKX REYNOSA MFG. NA 10HR08094

    Patients

    Seq Age Sex Outcome Treatment
    1 NA LIBERTY DIALYSIS MACHINE