BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT CONTINUOUS FLOW BREATHING CIRCUIT

    MDR report key: 2625374 · Received June 22, 2012

    Report

    Report Number
    9611451-2012-00412
    Event Type
    Malfunction
    Date Received
    June 22, 2012
    Date of Event
    May 16, 2012
    Report Date
    May 23, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K020332
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: SEVENTEEN COMPLAINT BREATHING CIRCUIT KITS, LOT 100707, WERE RETURNED TO THE MANUFACTURER AND VISUALLY INSPECTED. THE BREATHING CIRCUIT KITS WERE RETURNED IN CIRCUIT BAGS THAT WERE UNSEALED AND STAPLED AT THE OPENING. RESULTS: THE VISUAL INSPECTION OF THE RETURNED COMPLAINT BREATHING CIRCUIT KITS IDENTIFIED THE CHAMBERS IN THE KITS TO BE A MR225 MANUAL FILL INFANT HUMIDIFICATION CHAMBER, LOT 110830, INSTEAD OF MR290 AUTOFEED HUMIDIFICATION CHAMBERS CONFIRMING THE REPORTED FAULT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THIS PRODUCT. CONCLUSION: THE VISUAL INSPECTION CONFIRMED THE REPORTED FAULT. HOWEVER, IT IS NOT POSSIBLE THAT THE BREATHING CIRCUITS WOULD HAVE LEFT THE MANUFACTURERS FACILITY PACKED WITH THE INCORRECT CHAMBER AS FISHER & PAYKEL HEALTHCARE INFANT BREATHING CIRCUIT KITS DO NOT CONTAIN THE COMPLAINT MR225 CHAMBERS. IT SHOULD ALSO BE NOTED THAT THE CHAMBER LOT DATE INDICATES THAT IT WAS PRODUCED A YEAR AFTER THE BREATHING CIRCUIT KIT. THE BREATHING CIRCUIT KITS WERE RETURNED IN CIRCUIT BAGS THAT WERE UNSEALED AND STAPLED AT THE OPENING, INDICATING THAT IT IS POSSIBLE THE KITS WERE REPACKED AFTER LEAVING THE MANUFACTURER'S FACILITY. A PACK CARD IS DISPLAYED AT THE PACKING STATION TO PROVIDE THE PRODUCTION LINE STAFF WITH A VISUAL REPRESENTATION AND A LIST OF ALL THE COMPONENTS THEY ARE REQUIRED TO INCLUDE IN THE CURRENT MODEL OF BREATHING CIRCUIT KIT BEING PRODUCED. IT SHOULD BE NOTED THAT THIS IS THE ONLY COMPLAINT OF THIS NATURE THAT WE HAVE RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K020332. THE COMPLAINT DEVICES ARE CURRENTLY EN ROUTE TO THE MANUFACTURER. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT 20 RT324 INFANT BREATHING CIRCUIT KITS CONTAINED THE INCORRECT HUMIDIFICATION CHAMBER. INSTEAD OF THE MR290 AUTOFEED HUMIDIFICATION CHAMBER , THE RT324 KITS CONTAINED A MR225 MANUAL FILL INFANT HUMIDIFICATION CHAMBER. THIS WAS REPORTED PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT 20 RT324 INFANT BREATHING CIRCUIT KITS CONTAINED THE INCORRECT HUMIDIFICATION CHAMBER. INSTEAD OF THE MR290 AUTOFEED HUMIDIFICATION CHAMBER, THE RT324 KITS CONTAINED A MR225 MANUAL FILL INFANT HUMIDIFICATION CHAMBER. THIS WAS REPORTED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT CONTINUOUS FLOW BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT324 100707

    Patients

    Seq Age Sex Outcome Treatment
    1