BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, DUAL PATIENT CONNECT

    MDR report key: 2243539 · Received August 19, 2011

    Report

    Report Number
    8030665-2011-00100
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    March 15, 2011
    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
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEW: THE DHR OF THIS PRODUCT AND LOT WAS REVIEWED AND THE FOLLOWING WAS FOUND: THIS PRODUCT DID NOT HAVE ANY (B)(4). NO 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. NO REWORKS/RE-INSPECTIONS WERE PERFORMED TO THIS FINISH GOOD LOT #10KR08089. THE SAMPLE WAS NOT RECEIVED, THEREFORE, THE COMPLAINT IS DEEMED AS UNCONFIRMED. (B)(4) REYNOSA WILL CONTINUE MONITORING THIS TYPE OF INCIDENT PER CURRENT PROCEDURES.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PT REPORTED THAT THE CASSETTE WAS WET DURING TREATMENT. THERE IS NO REPORT OF PT ILL EFFECT. THE SAMPLE IS NOT AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTY CYCLER SET, DUAL PATIENT CONNECT PERITONEAL DIALYSIS TUBING SET FKX REYNOSA MANUFACTURING NA 10KR08089

    Patients

    Seq Age Sex Outcome Treatment
    1 NI LIBERTY DIALYSIS MACHINE