BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN./EXT. DL

    MDR report key: 2243544 · Received August 19, 2011

    Report

    Report Number
    8030665-2011-00033
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    March 3, 2011
    Report Date
    July 13, 2011
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE HISTORY RECORD REVIEW: THE DHR OF THIS PRODUCT 050-87216, LOT# 10NR08022 WAS REVIEWED AND THE FOLLOWING HIGHLIGHTS WERE FOUND: THE ASSEMBLY OF THIS PRODUCT DID NOT HAVE ANY NCR OR DEVIATIONS DOCUMENTED DURING THE MANUFACTURING PROCESS RELATED TO THIS FAILURE MODE. ALL APPLICABLE TESTS DURING THE IN-PROCESS AND FINAL INSPECTIONS WERE CONDUCTED IN ORDER TO ENSURE PRODUCT INTEGRITY AND DOCUMENTED WITH ACCEPTABLE RESULTS ACCORDING TO APPLICABLE PROCEDURES. (B)(4). IN PROCESS INSPECTION: THE LIBERTY CYCLER PROCESS WAS INVESTIGATED TO DETECT ANY POTENTIAL SOURCE OF DAMAGE OF THE FILM, FINDING FOLLOW TO BE CONSIDERED: AFTER THE LASER MACHINE SEALS THE FILM THE CASSETTE MOLDED PART, A 100% LEAK TEST IS PERFORMED TO THE CASSETTE ASSEMBLIES. THERE IS 100% LEAK TEST AFTER THE SET IS COMPLETELY ASSEMBLED. SAMPLE ANALYSIS: THE COMPLAINT IS DEEMED AS CONFIRMED THE ACTUAL SAMPLE HAS A HOLE ON THE CASSETTE FILM THAT CAUSES THE LEAK. CONCLUSION: THE REPORTED COMPLAINT IS CONFIRMED. THERE IS NO CAUSE IDENTIFIED DURING MANUFACTURING OF THIS PRODUCT SINCE PRODUCT IS 100% INSPECTED FOR LEAKS PRIOR TO PACKAGING. PERFORMED A VISUAL ANALYSIS TO THE CASSETTE WITH THE MICROSCOPE, NO MALFORMATIONS SUCH AS FLASHES THAT COULD CAUSE FILM DAMAGE WAS FOUND. ALL CORRECTIVE/PREVENTATIVE ACTIONS WERE COMPLETED ON 07/2010. (B)(4) HAS BEEN OPENED TO REDUCE COMPLAINT RATE AS A CONTINUOUS IMPROVEMENT INITIATIVE.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS NURSE WAS CONDUCTING A TRAINING SESSION WITH THE PATIENT AND NOTICED A FLUID LEAK COMING OUT OF THE MACHINE. UPON CHECKING, SHE NOTICED A CRACK IN THE CASSETTE. SHE HAS THE SAMPLE AT THE UNIT. THERE IS NO INFORMATION THAT THE PATIENT RECEIVED ANY TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTY CYCLER SET, SINGLE CONN./EXT. DL PERITONEAL DIALYSIS TUBING SET FKX REYNOSA MANUFACTURING NA 10NR08022

    Patients

    Seq Age Sex Outcome Treatment
    1 NI LIBERTY DIALYSIS MACHINE: