BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 3771180 · Received April 24, 2014

    Report

    Report Number
    9611451-2014-00366
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 20, 2014
    Report Date
    March 26, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) WHERE IT WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION OF THE RETURNED CIRCUIT REVEALED A HOLE APPROXIMATELY 45 CM FROM THE PROXIMAL CONNECTOR ON THE EVAQUA EXPIRATORY LIMB. A LOT CHECK REVEALED THREE OTHER COMPLAINTS OF THIS NATURE FOR LOT 130309. CONCLUSION: BASED ON THE INSPECTION CONDUCTED, THE EVAQUA EXPIRATORY LIMB OF THE RETURNED RT340 CIRCUIT APPEARED TO HAVE BEEN PUNCTURED WITH A BLUNT OBJECT. 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 IS PERFORMED EVERY 15 MINUTES. IF ANY FAULTS ARE DETECTED THE WHOLE BATCH IS PLACED ON HOLD FOR INVESTIGATION. THIS SUGGESTS THAT THE SUBJECT BREATHING CIRCUIT WAS DAMAGED AFTER IT WAS RELEASED FOR DISTRIBUTION. THE KEY DIFFERENCE BETWEEN FPH'S EVAQUA BREATHING CIRCUITS AND CONVENTIONAL BREATHING CIRCUITS IS THAT THE EXPIRATORY LIMB OF THE EVAQUA CIRCUITS SUCH AS THE RT340 IS COMPOSED OF A THIN, SEMI-PERMEABLE FILM SPECIALLY DESIGNED TO ALLOW WATER VAPOUR FROM EXPIRED VENTILATORY GAS TO PASS THROUGH. THE EVAQUA EXPIRATORY TUBE HAS A PROTECTIVE MESH WHICH PREVENTS DAMAGE TO THE WALLS OF THE TUBE, HOWEVER THE EVAQUA TUBING REMAINS MORE SUSCEPTIBLE TO DAMAGE THAN CONVENTIONAL CIRCUITS WHEN EXPOSED TO ROUGH HANDLING OR DAMAGE CAUSED BY BLUNT OBJECTS AND NON-FPH CIRCUIT HANGERS. THE USER INSTRUCTIONS SUPPLIED WITH THE RT340 BREATHING CIRCUIT STATE: "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." "SET APPROPRIATE VENTILATOR ALARMS". "FIT ONLY THE SUPPLIED FISHER & PAYKEL HEALTHCARE CIRCUIT HANGER WITH CARE TO AVOID CIRCUIT DAMAGE." THE HOSPITAL CORRECTLY CHECKED THE RT340 BREATHING CIRCUIT BEFORE PATIENT USE, THIS IS IN LINE WITH OUR USER INSTRUCTIONS.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT AN RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT FAILED THE LEAK TEST PRIOR TO PATIENT USE. THEY FURTHER REPORTED THAT THE EXPIRATORY LIMB WAS DAMAGED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT AN RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT FAILED THE LEAK TEST PRIOR TO PATIENT USE. THEY FURTHER REPORTED THAT THE EXPIRATORY LIMB WAS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250036 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT340 130309

    Patients

    Seq Age Sex Outcome Treatment
    1