BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 3526948 · Received December 18, 2013

    Report

    Report Number
    9611451-2013-01052
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Date of Event
    November 26, 2013
    Report Date
    November 27, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE TWO COMPLAINT RT340 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT WERE RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4). ONE CIRCUIT WAS FROM LOT 130701 (MANUFACTURED 1 JULY 2013) AND THE OTHER CIRCUIT WAS FROM LOT 130730 (MANUFACTURED 30 JULY 2013). BOTH CIRCUITS WERE VISUALLY INSPECTED, PRESSURE TESTED AND IMMERSED IN A WATER BATH TO TEST FOR LEAKS. RESULTS: THE PRESSURE TEST RESULT REVEALED THAT BOTH CIRCUITS WERE OUT OF SPECIFICATION DUE TO LEAKAGE COMING FROM THE TWO PATIENT END CONNECTORS. THIS WAS CONFIRMED WHEN THE SUBJECT BREATHING CIRCUITS WERE IMMERSED IN THE WATER BATH. VISUAL INSPECTION REVEALED THAT THERE WAS NOT ENOUGH GLUE PRESENT IN THE PROXIMAL CONNECTORS, CAUSING THE REPORTED LEAK. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR EITHER LOT NUMBER. CONCLUSION: THE OBSERVED LEAK WAS CAUSED BY INSUFFICIENT GLUE BEING INJECTED INTO THE PROXIMAL CONNECTOR SUCH THAT THEY DID NOT FORM A PERMANENT SEAL AFTER RELEASE FOR DISTRIBUTION. ALL RT340 BREATHING CIRCUITS ARE VISUALLY INSPECTED AND PRESSURE TESTED FOR LEAKS BEFORE RELEASING FOR DISTRIBUTION. ANY BREATHING CIRCUIT WHICH FAILS ANY OF THESE TESTS IS DISCARDED. IN ADDITION, TUBE WEIGHING AND BOND STRENGTH TESTING ARE PERFORMED EVERY (B)(4). IF ANY FAULTS ARE DETECTED THE WHOLE BATCH IS PLACED ON HOLD FOR INVESTIGATION. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT340 ADULT DUAL HEATED 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 RT340 BREATHING CIRCUITS 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 FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT TWO RT340 ADULT BREATHING CIRCUITS FAILED THE VELA VENTILATOR LEAK TEST THIS WAS FOUND PRIOR TO USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663566 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT340 130701

    Patients

    Seq Age Sex Outcome Treatment
    1 VELA VENTILATOR