BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT CONTINUOUS FLOW BREATHING CIRCUIT

    MDR report key: 2161131 · Received July 13, 2011

    Report

    Report Number
    9611451-2011-00419
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    March 29, 2011
    Report Date
    June 23, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K020332
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT DEVICE WAS RECEIVED IN AN UNSEALED BAG AND WAS VISUALLY INSPECTED. RESULTS: IT WAS OBSERVED THAT THE OFFSET ADAPTOR WAS MISSING FROM THE END OF THE INSPIRATORY LIMB. A LOT CHECK REVEALED ONE OTHER COMPLAINT FOR THIS LOT NUMBER. CONCLUSION: THE LIKELY CAUSE OF THIS IS FAILURE OF PRODUCTION LINE STAFF TO CONNECT THIS COMPONENT WHEN ASSEMBLING THE BREATHING CIRCUIT AND FAILURE OF PRODUCTION LINE STAFF TO CHECK THIS COMPONENT DURING VISUAL INSPECTION OF THE BREATHING CIRCUIT. OPERATING PROCEDURES ARE IN PLACE TO ASSIST THE OPERATORS ON THE PRODUCTION LINE TO CORRECTLY PACK BREATHING CIRCUITS. A PACK CARD DETAILING ALL COMPONENTS REQUIRED IS DISPLAYED AT THE PACKING STATION. EACH COMPLETED CIRCUIT PACK IS THEN WEIGHED TO ENSURE THAT EVERY COMPONENT CIRCUIT PACK IS ACCOUNTED FOR. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN ADAPTOR WAS MISSING FROM AN RT329 INFANT BREATHING CIRCUIT KIT. THIS WAS FOUND BEFORE USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT CONTINUOUS FLOW BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT329 101115

    Patients

    Seq Age Sex Outcome Treatment
    1