BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    MDR report key: 3372195 · Received September 26, 2013

    Report

    Report Number
    9611451-2013-00736
    Event Type
    Malfunction
    Date Received
    September 26, 2013
    Date of Event
    August 27, 2013
    Report Date
    August 29, 2013
    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 RT205 ADULT INSPIRATORY HEATED BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IS SIMILAR TO A PRODUCT WHICH SOLD IN THE USA. THE 510(K) NUMBER FOR THAT PRODUCT IS K983112. METHOD: TWO RT205 ADULT INSPIRATORY HEATED BREATHING CIRCUITS FROM LOT 130424 WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN NEW ZEALAND FOR EVALUATION. THEY WERE PRESSURE TESTED AND SUBSEQUENTLY SUBMERGED IN A WATER BATH TO TEST FOR LEAK. RESULTS: PRESSURE TEST REVEALED THAT BOTH OF THE RETURNED BREATHING CIRCUITS EXHIBITED LEAK AND WERE OUT OF SPECIFICATION. THE WATER BATH TEST SHOWED THAT THE LEAKS WERE THROUGH THE CONNECTION BETWEEN THE LID AND BOWL OF THE WATER TRAPS ON BOTH OF THE RETURNED BREATHING CIRCUITS. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT 130424. CONCLUSION: THE BREATHING CIRCUIT WATER TRAP CONSISTS OF A BOWL AND LID, WHICH CAN BE SEPARATED TO ALLOW THE CAREGIVER TO EMPTY THE WATER TRAP. ALL BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAKS DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THAT ANY LEAK MUST HAVE DEVELOPED AFTER THE BREATHING CIRCUITS WERE RELEASED FOR DISTRIBUTION, DURING TRANSPORT, STORAGE OR USE, POSSIBLY BY DISTORTION OF THE WATER TRAP WHEN THE BOWL WAS CONNECTED. THE HOSPITAL CORRECTLY FOLLOWED OUR USER INSTRUCTIONS AND DETECTED THE LEAKS DURING A SETUP CHECK BEFORE USE ON A PATIENT.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT TWO RT205 ADULT INSPIRATORY HEATED BREATHING CIRCUITS FAILED THE LEAK TEST ON A PB840 VENTILATOR. THESE WERE FOUND DURING THE SETUP CHECK AND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486941 ADULT INSPIRATORY HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT205 130424

    Patients

    Seq Age Sex Outcome Treatment
    1 PURITAN BENNETT 840 VENTILATOR