BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN./EXT. DL

    MDR report key: 2243531 · Received August 19, 2011

    Report

    Report Number
    8030665-2011-00070
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    December 1, 2010
    Report Date
    August 19, 2011
    Manufacturer
    REYNOSE MANUFACTURING
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEW: THE DHR OF THIS PRODUCT 050-87216 AND LOT 10LR08002 WAS REVIEWED AND THE FOLLOWING WAS FOUND: THE ASSEMBLY OF THIS PRODUCT DID NOT HAVE ANY NCR OR DEVIATIONS DOCUMENTED DURING MANUFACTURING PROCESS. ALL APPLICABLE TESTS DURING 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: K301003, K241044 USED PRODUCT CODE 050-87216 LOT NUMBER 10LR08002 WAS REVIEWED AND NO ISSUES WERE REPORTED DURING THE MANUFACTURING PROCESS. THE COMPLAINT DATABASE WAS CONSULTED HAVING THIS TO CONSIDER: NO OTHER COMPLAINT HAD BEEN RECEIVED WITH THIS SAME FAILURE DESCRIPTION FOR THIS LOT. SAMPLE ANALYSIS: REYNOSA RECEIVED AN ACTUAL SAMPLES FROM THIS CODE AND FOUR COMPANION SAMPLES. PERFORMED A VISUAL ANALYSIS TO THE ACTUAL SAMPLE AFTER LEAK TEST AND SOME PINHOLES ON THE FILM CAUSES THE LEAK. VISUAL INSPECTION WITH THE MICROSCOPE WAS PERFORMED TO THE CASSETTE HARD PLASTIC AFTER LEAK TEST AND SOME DAMAGE WAS FOUND THAT MATCHES WITH PINHOLES ON THE FILM OF THE CASSETTE. FUNCTIONAL TEST WITH THE LIBERTY CYCLER MACHINE WAS PERFORMED TO THE FOUR COMPANION SAMPLES WITH THE FOLLOWING RESULTS: THE CASSETTE COMPANION DID NOT SHOW ANY PROBLEMS AND THE TREATMENTS WERE COMPLETED SUCCESSFULLY WITHOUT ANY LEAKS. CONCLUSION: THE REPORTED COMPLAINT IS CONFIRMED THE ACTUAL SAMPLE HAS A HOLE ON THE CASSETTE FILM THAT CAUSES A LEAK. CONCLUSION: THE REPORTED COMPLAINT IS CONFIRMED THE ACTUAL SAMPLE HAS A HOLE ON THE CASSETTE FILM THAT CAUSES A LEAK. CONCLUSION: THERE IS NO CAUSE IDENTIFIED DURING MANUFACTURING OF THE PRODUCT SINCE PRODUCT IS 100% INSPECTED FOR LEAKS PRIOR PACKAGING. PERFORMED A VISUAL ANALYSIS TO THE CASSETTE WITH THE MICROSCOPE. NO MALFUNCTIONS SUCH AS FLASHES THAT COULD CAUSE FILM DAMAGES WERE FOUND. A CAPA (B)(4) WAS OPENED FOR CASSETTE LEAKS AND THE CORRECTIVE/PREVENTATIVE ACTIONS WERE COMPLETED LAST JULY 2010. ITS MONITORING PHASE HAS NOT ENDED THUS CAPA (B)(4) IS CONSIDERED NOT EFFECTIVE AND HAS BEEN RE-OPENED TO INVESTIGATE FURTHER AND WORK ON NEW CORRECTIVE/PREVENTATIVE ACTIONS TO MITIGATE COMPLAINTS.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PATIENT HAS REPORTED AN ERROR MESSAGE AND SHE DECIDED TO CHANGE THE CASSETTE. SHE FOUND A FLUID LEAK AT THE CASSETTE. THERE IS NO REPORT OF PATIENT ILL EFFECT. SAMPLE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTY CYCLER SET, SINGLE CONN./EXT. DL PERITONEAL DIALYSIS TUBING TREATMENT SET FKX REYNOSE MANUFACTURING NA 10LR08002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA