BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, DUAL PATIENT CONNECT

    MDR report key: 2243521 · Received August 19, 2011

    Report

    Report Number
    8030665-2011-00060
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    January 14, 2011
    Report Date
    August 9, 2011
    Manufacturer
    REYNOSA MFG
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE HISTORY RECORD REVIEW: THE DHR FOR THIS PRODUCT AND LOT WAS REVIEWED AND THE FOLLOWING WAS FOUND: THIS PRODUCT DID NOT HAVE ANY NCR. NO DEVIATION WAS 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 DOCUMENTED WITH ACCEPTABLE RESULTS TO APPLICABLE PROCEDURES. NO REWORKS/RE-INSPECTIONS WERE PERFORMED TO FINISH GOOD LOT #8LR237. THE SAMPLE WAS NOT RECEIVED FOR EVAL, 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 NURSE REPORTED THAT WHILE TRAINING A PT, SHE NOTICED A LEAK COMING FROM THE MACHINE - INSIDE OF CYCLER WAS WET FROM THE CASSETTE THAT HAD BEEN LEAKING. THERE IS NO REPORT OF PT ILL EFFECT. THE SAMPLE WAS NOT AVAILABLE FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTY CYCLER SET, DUAL PATIENT CONNECT PERITONEAL DIALYSIS TUBING SET FKX REYNOSA MFG NA 8LR237

    Patients

    Seq Age Sex Outcome Treatment
    1 NI LIBERTY DIALYSIS MACHINE