BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    MDR report key: 3532175 · Received December 22, 2013

    Report

    Report Number
    9611451-2013-01044
    Event Type
    Malfunction
    Date Received
    December 22, 2013
    Date of Event
    November 27, 2013
    Report Date
    December 2, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    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 RT105 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: THE TWO COMPLAINT RT105 BREATHING CIRCUITS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. THE BREATHING CIRCUITS WERE PRESSURE TESTED AND SUBSEQUENTLY SUBMERGED IN A WATER BATH TO TEST FOR LEAK. RESULTS: THE PRESSURE TEST REVEALED THAT THE RETURNED RT105 BREATHING CIRCUITS EXHIBITED LEAK AND WERE OUT OF SPECIFICATION. THE WATER BATH TEST SHOWED THAT THE LEAK IS THROUGH THE CONNECTION BETWEEN THE LID AND BOWL OF THE WATER TRAP FOR BOTH CIRCUITS. A LOT CHECK REVEALED FOUR SIMILAR COMPLAINTS FOR LOT NUMBER 130515. 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 CIRCUIT WAS RELEASED FOR DISTRIBUTION, DURING TRANSPORT, STORAGE OR USE, POSSIBLY BY DISTORTION OF THE WATER TRAP WHEN THE BOWL WAS CONNECTED. OUR USER INSTRUCTIONS THAT ACCOMPANY THE RT105 ADULT 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." HOSPITAL STAFF CORRECTLY CHECKED THE BREATHING CIRCUIT BEFORE PATIENT USE, WHICH IS IN LINE WITH OUR USER INSTRUCTIONS.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT TWO RT105 ADULT INSPIRATORY HEATED BREATHING CIRCUITS FAILED THE LEAK TEST ON A SERVO-I VENTILATOR. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671167 ADULT INSPIRATORY HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED RT105 130515

    Patients

    Seq Age Sex Outcome Treatment
    1 SERVO-I VENTILATOR