BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 3630157 · Received February 17, 2014

    Report

    Report Number
    9611451-2014-00132
    Event Type
    Malfunction
    Date Received
    February 17, 2014
    Date of Event
    January 23, 2014
    Report Date
    January 27, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    K122432
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(6) FOR EVALUATION. IT WAS VISUALLY INSPECTED AND PRESSURE TESTED FOR LEAKS. RESULTS: VISUAL INSPECTION REVEALED A CRACK ON THE PATIENT END EVAQUA2 CONNECTOR. THE CRACK STARTS AT THE Y-PIECE AND STRETCHES TOWARDS THE TUBING. THE BREATHING CIRCUIT WAS PRESSURE TESTED AND THE CIRCUIT WAS FOUND TO BE WITHIN SPECIFICATION. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 130804. CONCLUSION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE DAMAGE NOTED ON THE RETURNED RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT. ALL RT380 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 15 MINUTES. IF ANY FAULTS ARE DETECTED THE WHOLE BATCH IS PLACED ON HOLD FOR INVESTIGATION. THIS SUGGESTS THAT THE SUBJECT RT380 WAS DAMAGED AFTER IT WAS RELEASED FOR DISTRIBUTION. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT380 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 STAFF CORRECTLY CHECKED THE SUBJECT 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 TO A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT AN RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT FAILED THE VENTILATOR LEAK TEST. THE HOSPITAL FURTHER REPORTED THAT THEY FOUND A CRACK ON THE PATIENT END COLLAR. THIS WAS FOUND BEFORE PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100096 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT380 130804

    Patients

    Seq Age Sex Outcome Treatment
    1 SERVO-I VENTILATOR