BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 3482888 · Received November 21, 2013

    Report

    Report Number
    9611451-2013-00934
    Event Type
    Malfunction
    Date Received
    November 21, 2013
    Date of Event
    October 21, 2013
    Report Date
    October 25, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    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 RT345 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K983112. METHOD: THE COMPLAINT RT345 ADULT BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. THE BREATHING CIRCUIT WAS PRESSURE TESTED, VISUALLY INSPECTED AND IMMERSED IN A WATER BATH TO TEST FOR LEAKS. RESULTS: THE PRESSURE TEST REVEALED THAT THE CIRCUIT WAS OUT OF SPECIFICATION DUE TO LEAKAGE COMING FROM THE PATIENT END CONNECTOR. THIS WAS CONFIRMED WHEN THE SUBJECT BREATHING CIRCUIT WAS IMMERSED IN THE WATER BATH. VISUAL INSPECTION REVEALED THAT THERE WAS NOT ENOUGH GLUE PRESENT IN THE EVAQUA LIMB CONNECTOR, CAUSING THE REPORTED LEAK. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 130617. CONCLUSION: ALL BREATHING CIRCUITS ARE VISUALLY INSPECTED AND PRESSURE TESTED BEFORE RELEASING FOR DISTRIBUTION, AND THOSE THAT FAIL ARE REJECTED. THE OBSERVED LEAK WAS CAUSED BY INSUFFICIENT GLUE BEING INJECTED INTO THE EVAQUA LIMB CONNECTOR SUCH THAT IT DID NOT FORM A PERMANENT SEAL DURING THE ASSEMBLY PROCESS. THE USER INSTRUCTIONS SUPPLIED WITH ADULT EVAQUA BREATHING CIRCUIT STATE THE FOLLOWING: - "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. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT AN RT345 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT FAILED THE VENTILATOR LEAK TEST. THIS WAS OBSERVED BEFORE PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604963 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT345 130617

    Patients

    Seq Age Sex Outcome Treatment
    1 EVITA VENTILATOR