BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM DEFINED PRODUCT

    MDR report key: 4211646 · Received October 29, 2014

    Report

    Report Number
    2015691-2014-02564
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    September 29, 2014
    Report Date
    October 1, 2014
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RECEIVED ONE USED MERIT FLUSH DEVICE WITH ATTACHED IV SET AND PRESSURE TUBING . A PRELIMINARY EVALUATION ON THE USED KIT REVEALED THAT ALL CONNECTIONS APPEARED TIGHT. THERE WAS NO LEAKAGE DETECTED FROM THE UNIT DURING LEAK TESTING. A VISUAL EXAMINATION INDICATED THAT THE ENDS OF THE SILICONE HOUSING DID NOT TOUCH THE EDGES OF THE PLASTIC HOUSING. THE FLOW RATE WAS NOT ABLE TO BE MEASURED DURING EVALUATION. THE ROOT CAUSE ANALYSIS AND IMPLEMENTATION OF ANY NECESSARY CORRECTIVE ACTIONS HAS BEEN REQUESTED OF THE SUPPLIER. A SUPPLEMENTAL WILL BE FORTHCOMING WITH THE DEVICE HISTORY RESULTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FLOW RATE WAS OBSERVED TO BE HIGHER THAN USUAL DURING USE. IT WAS STATED THAT A 500ML OF BAG WITH INFUSION SOLUTION BECAME EMPTY IN 24 HOURS. IT WAS ALSO INDICATED THAT FIVE UNOPENED KITS FROM THE SAME BOX WILL BE RETURNED TOGETHER WITH THE COMPLAINT SAMPLE DUE TO LOSS OF FAITH. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692493 CUSTOM DEFINED PRODUCT TRANSDUCER, PRESSURE, CATHETER TIP DXO EDWARDS LIFESCIENCES DR CK0204YT EF0002MT

    Patients

    Seq Age Sex Outcome Treatment
    1