BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT CONTINUOUS FLOW BREATHING CIRCUIT

    MDR report key: 1982062 · Received February 8, 2011

    Report

    Report Number
    9611451-2011-00061
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Report Date
    January 11, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K020332
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE IS NOT EXPECTED TO BE RETURNED TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. OUR ANALYSIS IS ACCORDINGLY BASED ON THE DESCRIPTION OF EVENTS, ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER AND OUR KNOWLEDGE OF THE PRODUCTS. A LOT CHECK REVEALED NO OTHER COMPLAINT OF THIS NATURE FOR THIS LOT NUMBER. THE RT329 INFANT CONTINUOUS FLOW BREATHING CIRCUIT KIT INCLUDES A PRESSURE MANIFOLD WHICH ENSURES PATIENT SAFETY BY LIMITING THE PRESSURE DELIVERED IN AN EVENT OF AN OCCLUSION, AS WELL AS ALLOWING CONNECTION TO A PRESSURE MONITORING DEVICE OR AN OXYGEN ANALYZER. THE MANIFOLD IS PACKED WITH THE BLUE CAP IN PLACE. THE PRESSURE MANIFOLD IS PRESSURE TESTED AND VISUALLY INSPECTED PRIOR TO LEAVING OUR FACILITY. ANY OF THOSE THAT FAIL THE PRESSURE TEST ARE DISCARDED. THEREFORE THIS SUGGESTS THAT IT IS LIKELY THAT THE CAP BECAME LOOSE POSTPRODUCTION DURING TRANSPORT. OUR USER INSTRUCTIONS STATE THE FOLLOWING: "CHECK THAT ALL CONNECTIONS, CAPS AND/OR PLUGS ARE TIGHT BEFORE USE." "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE BLUE PLUG ON THE PRESSURE MANIFOLD OF AN RT329 INFANT CONTINUOUS FLOW BREATHING CIRCUIT KIT "EITHER CAME OUT OR WAS LOOSE THEN CAME OUT OVER TIME" FROM THE CHAMBER PORT AFTER ONE DAY OF USE. THE HOSPITAL REPORTED THAT THERE WERE NO PHYSICAL DAMAGE TO THE CHAMBER OR PRESSURE MANIFOLD. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT CONTINUOUS FLOW BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT329 101020

    Patients

    Seq Age Sex Outcome Treatment
    1