BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    MDR report key: 3372207 · Received September 26, 2013

    Report

    Report Number
    9611451-2013-00735
    Event Type
    Malfunction
    Date Received
    September 26, 2013
    Date of Event
    July 1, 2013
    Report Date
    August 28, 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 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. LOT & DATE OF MANUFACTURE INFORMATION OF THE RETURNED RT105 BREATHING CIRCUITS: DEVICE 1: LOT 130306; DATE OF MANUFACTURE: 6 MARCH 2013; DEVICE 2: LOT 130517; DATE OF MANUFACTURE: 17 MAY 2013; DEVICE 3 & 4: LOT 130415; DATE OF MANUFACTURE: 15 APRIL 2013; DEVICE 5 & 6: LOT UNKNOWN; DATE OF MANUFACTURE: UNKNOWN. METHOD: ONLY THE EXPIRATORY LIMBS OF THE COMPLAINT RT105 BREATHING CIRCUITS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. THEY WERE PRESSURE TESTED AND SUBSEQUENTLY SUBMERGED IN A WATER BATH TO TEST FOR LEAK. RESULTS: PRESSURE TEST REVEALED THAT ALL OF THE RETURNED EXPIRATORY LIMBS EXHIBITED LEAK AND WERE OUT OF SPECIFICATION. THE WATER BATH TEST SHOWED THAT THE LEAKS ON ALL SIX EXPIRATORY LIMBS WERE THROUGH THE CONNECTION BETWEEN THE LID AND BOWL OF THE WATER TRAPS. A LOT CHECK REVEALED NO COMPLAINTS OF THIS NATURE FOR LOT 130306 AND ONE COMPLAINT FOR LOT 130517 & 130415. 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. 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." 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 SIX RT105 ADULT INSPIRATORY HEATED BREATHING CIRCUITS FAILED THE LEAK TEST ON A SERVO VENTILATOR. THESE WERE FOUND DURING THE SETUP CHECK AND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487725 ADULT INSPIRATORY HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT105 130306, 130415, 130517

    Patients

    Seq Age Sex Outcome Treatment
    1 SERVO VENTILATOR