BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BIAS FLOW BREATHING CIRCUIT

    MDR report key: 2479744 · Received March 6, 2012

    Report

    Report Number
    9611451-2012-00127
    Event Type
    Malfunction
    Date Received
    March 6, 2012
    Date of Event
    February 7, 2012
    Report Date
    February 7, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT125 BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IS SIMILAR TO A PRODUCT WHICH SOLD IN THE USA. THE 510(K) NUMBER OF THE SIMILAR PRODUCT IS K20332. METHOD: SEVEN COMPLAINT RT125 BREATHING CIRCUITS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION, ONE FROM LOT 100802 AND SIX FROM LOT 100810. THE CIRCUITS WERE PRESSURE TESTED AND ALSO SUBMERGED IN A WATER BATH TO TEST FOR LEAKS. RESULTS: THE PRESSURE TEST CONFIRMED THAT TWO CIRCUITS FROM LOT 100810 AND ONE FROM LOT 100802 WERE OUT OF SPECIFICATION. UPON SUBMERSION IN A WATER BATH, THE LEAK WAS CONFIRMED TO BE IN THE SWIVEL IN ALL THREE OF THESE CIRCUITS. THE REMAINING FOUR CIRCUITS FROM LOT 100810 TESTED WITHIN SPECIFICATION AND NO FAULT COULD BE FOUND WITH THEM. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS TYPE FOR EITHER LOT NUMBER. CONCLUSION: THE LEAK IN THE THREE INFANT BREATHING CIRCUITS WAS CAUSED BY AN INSUFFICIENT SEAL BETWEEN THE TWO PARTS OF THE INFANT Y-PIECE SWIVEL THAT ARE HELD TOGETHER BY A SNAP-FIT. ALL BREATHING CIRCUITS ARE PRESSURE TESTED DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THE LEAK DEVELOPED POST PRODUCTION. OUR MONITORING AND TRENDING OF SWIVEL LEAKS IN INFANT BREATHING CIRCUITS HAS A RATE OF OCCURRENCE OF (B)(4) DEVICES PER MILLION SOLD WORLDWIDE IN THE LAST YEAR TO THE END OF FEBRUARY 2012.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT SOME RT125 INFANT BIAS FLOW BREATHING CIRCUITS FAILED THE VENTILATOR LEAK TEST. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT BIAS FLOW BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT125 100802

    Patients

    Seq Age Sex Outcome Treatment
    1 VIASYS VIP BIRD VENTILATOR