BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, SINGLE PATIENT CONN

    MDR report key: 2243499 · Received August 19, 2011

    Report

    Report Number
    8030665-2011-00067
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    November 16, 2010
    Report Date
    August 19, 2011
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEW: THE DHR OF THIS PRODUCT 050-87215 LOT #10BR08058 WAS REVIEWED AND THE FOLLOWING HIGHLIGHTS WERE FOUND: THE ASSEMBLY OF THIS PRODUCT DID NOT HAVE ANY NCRS OR DEVIATION WAS DOCUMENTED DURING THE MANUFACTURING PROCESS. ALL THE 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. LIBERTY CASSETTE LOT NUMBER B051009 USED TO PRODUCT CODE 050-87215 LOT NUMBER 10BR08058 WAS REVIEWED AND NO ISSUES WERE REPORTED DURING INCOMING INSPECTION. THE COMPLAINT DATABASE WAS CONSULTING HAVING THIS TO CONSIDER: NO OTHER COMPLAINT HAS BEEN RECEIVED WITH SAME FAILURE DESCRIPTION AS THIS LOT. SAMPLE ANALYSIS: THE COMPARISON SAMPLES DID NOT SHOW ANY DEFECTS. THE COMPLAINT IS DEEMED AS NOT CONFIRMED. CONCLUSIONS: THE COMPLAINT IS NOT CONFIRMED. THE COMPANION SAMPLES DID NOT SHOW ANY DEFECTS. SINCE THE COMPLAINT WAS NOT CONFIRMED, NO CORRECTIVE ACTION IS DOCUMENTED AT THIS TIME. FMC (B)(4) WILL CONTINUE TO MONITOR THIS TYPE OF INCIDENT PER PROCEDURE.

    Description of Event or Problem · 1

    A REPORT HAS BEEN RECEIVED REGARDING THAT THE CASSETTE WAS LEAKING WHEN THE CASSETTE DOOR WAS OPENED. COMPANION SAMPLES ARE AVAILABLE AS THE ACTUAL CASSETTE WAS DISCARDED. THERE IS NO INFORMATION OF ILL EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTY CYCLER SET, SINGLE PATIENT CONN PERITONEAL DIALYSIS TUBING TREATMENT SET FKX REYNOSA MANUFACTURING NA 10BR08058

    Patients

    Seq Age Sex Outcome Treatment
    1 NA LIBERTY DIALYSIS MACHINE