BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    MDR report key: 3385178 · Received October 3, 2013

    Report

    Report Number
    9611451-2013-00760
    Event Type
    Malfunction
    Date Received
    October 3, 2013
    Date of Event
    August 21, 2013
    Report Date
    September 5, 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 RT212 ADULT INSPIRATORY HEATED BREATHING CIRCUIT 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 K983112. METHOD: TWO RT212 ADULT BREATHING CIRCUITS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN NEW ZEALAND FOR EVALUATION. ONE WAS FROM LOT 120124 WHILE THE LOT NUMBER OF THE OTHER CIRCUIT WAS NOT PROVIDED. BOTH CIRCUITS WERE PRESSURE TESTED FOR LEAK AND WERE SUBSEQUENTLY SUBMERGED IN A WATER BATH TO IDENTIFY THE SOURCE OF THE LEAK. RESULTS: THE PRESSURE TEST REVEALED THAT BOTH OF THE RETURNED RT212 ADULT BREATHING CIRCUITS WERE OUT OF SPECIFICATION. A WATER BATH TEST IDENTIFIED THE SOURCE OF THE LEAK TO BE BETWEEN THE WATER TRAP LID AND BOWL ON BOTH OF THE CIRCUITS. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 120124. CONCLUSION: THE BREATHING CIRCUIT WATER TRAP CONSISTS OF A BOWL AND A 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 ANY LEAK MUST HAVE DEVELOPED AFTER THE CIRCUIT WAS RELEASED FOR DISTRIBUTION MOST LIKELY DURING TRANSPORT, STORAGE OR USE, POSSIBLY BY DISTORTION OF THE WATER TRAP WHEN THE BOWL WAS CONNECTED. OUR USER INSTRUCTIONS THAT ACCOMPANY THE RT212 ADULT INSPIRATORY HEATED BREATHING CIRCUIT STATE THE FOLLOWING: - "CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE." - "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." - "SET APPROPRIATE VENTILATOR ALARMS."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT FOUR RT212 ADULT BREATHING CIRCUITS WERE LEAKING AIR FROM THE WATER TRAP AFTER ONE WEEK OF USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499469 ADULT INSPIRATORY HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT212 120124

    Patients

    Seq Age Sex Outcome Treatment
    1