BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL-HEATED WITH EVAQUA BREATHING CIRCUIT

    MDR report key: 3223185 · Received July 12, 2013

    Report

    Report Number
    9611451-2013-00526
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 14, 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 COMPLAINT BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR EVALUATION. THE COMPLAINT BREATHING CIRCUIT WAS VISUALLY INSPECTED, PRESSURE TESTED AND SUBMERGED IN A WATER BATH TO TEST FOR LEAKS. RESULTS: THE PRESSURE TEST REVEALED A LEAK IN THE EVAQUA (EXPIRATORY) LIMB OF THE RETURNED BREATHING CIRCUIT. THE WATER BATH TEST IDENTIFIED THE LEAK TO BE LOCATED AT THE PATIENT END CONNECTOR OF THE EVAQUA LIMB. A VISUAL INSPECTION IDENTIFIED THAT THERE WAS INSUFFICIENT GLUE IN THE PATIENT END CONNECTOR. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THIS LOT NUMBER. CONCLUSION: THE LEAK OBSERVED WAS DUE TO INSUFFICIENT GLUE IN THE EVAQUA EXPIRATORY LIMB CONNECTOR. ALL RT340 BREATHING CIRCUITS ARE VISUALLY INSPECTED AND PRESSURE TESTED BEFORE LEAVING THE PRODUCTION LINE, AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THE LEAK DEVELOPED UPON SET UP FOR USE AFTER RELEASE FOR DISTRIBUTION. OUR 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."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN RT340 ADULT DUAL-HEATED WITH EVAQUA BREATHING CIRCUIT DID NOT PASS THE PB840 VENTILATOR LEAK TEST. THIS WAS REPORTED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322884 ADULT DUAL-HEATED WITH EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT340 121129

    Patients

    Seq Age Sex Outcome Treatment
    1 PB840 VENTILATOR