BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN./EXT. DL

    MDR report key: 3102327 · Received April 30, 2013

    Report

    Report Number
    8030665-2013-00243
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 1, 2013
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED NO DEFINITIVE CONCLUSION CAN BE DRAWN. THE ACTUAL DEVICE IN QUESTION WAS NOT RETURNED FOR EVALUATION. THE PATIENT RETURNED A DEVICE FROM A DIFFERENT LOT WHICH WAS EVALUATED INCLUDING FUNCTIONAL TESTING AND WAS DETERMINED TO MEET SPECIFICATION. A REVIEW OF MANUFACTURING RECORDS WAS PERFORMED AND THERE WERE NO DEVIATIONS OR NONCONFORMANCES DURING THE MANUFACTURING PROCESS. IN ADDITION, THE BATCH RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION. SEE MDR 8030665-2013-00240, 8030665-2013-00241 8030665-2013-00243, 8030665-2013-00244, 8030665-2013-00245, 8030665-2013-00246, 8030665-2013-00247.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED BY THE PATIENT'S WIFE: THE PATIENT REPORTEDLY EXPERIENCED SOLUTION LEAKING OUT OF THE CASSETTE AND INTO THE CYCLER. PATIENT HAS BEEN FINDING FLUID AND MOISTURE INSIDE THEIR CYCLER EVERY NIGHT SINCE MONDAY OF THE LAST WEEK ((B)(6) 2013). THE CASSETTE'S DID NOT APPEAR DAMAGED AND IN EACH CASE THE FLUID WAS NOT NOTICED UNTIL IT WAS TIME TO REMOVE THE CASSETTE FROM THE CYCLER. PATIENT'S WIFE STATED THAT THERE WERE NO PROPHYLACTIC ANTIBIOTICS GIVEN OR THE NEED FOR MEDICAL INTERVENTION OF ANY TYPE. THE PATIENT CONTINUES WITH CCPD IN STABLE CONDITION. THERE WAS NO SUCH PATIENT INJURY HOWEVER, AN MDR IS BEING FILED TO DOCUMENT THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186994 LIBERTY CYCLER SET, SINGLE CONN./EXT. DL FKX REYNOSA MANUFACTURING 13AR08889

    Patients

    Seq Age Sex Outcome Treatment
    1