BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 2213609 · Received August 16, 2011

    Report

    Report Number
    9611451-2011-00495
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 20, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    SEE H.10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT SOLD IN THE USA. (B)(4). THE RETURNED COMPLAINT EXPIRATORY LIMB OF THE BREATHING CIRCUIT WAS VISUALLY INSPECTED AND PRESSURE TESTED. THE VISUAL INSPECTION REVEALED A HOLE APPROXIMATELY 47CM AWAY FROM THE PATIENT END CONNECTOR. THE HOLE HAD THE APPEARANCE OF HAVING BEEN PUNCTURED OR SCRATCHED WITH A BLUNT OBJECT. THE PRESSURE TEST REVEALED EXCESSIVE LEAK, DUE TO THE OBSERVED DAMAGE. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR THIS LOT NUMBER. BASED ON INSPECTION OF THE HOLE, THE CIRCUIT WAS PUNCTURED OR SCRATCHED BY A BLUNT OBJECT. ALL BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAKS PRIOR TO DISTRIBUTION. ANY BREATHING CIRCUIT WHICH DOES NOT PASS THE PRESSURE TEST IS DISCARDED. THIS SUGGESTS THAT THE BREATHING CIRCUIT WAS PUNCTURED POST-PRODUCTION, POSSIBLY DURING STORAGE OR SETUP. THE KEY DIFFERENCE BETWEEN FPH'S EVAQUA BREATHING CIRCUITS AND CONVENTIONAL BREATHING CIRCUITS IS THAT THE EXPIRATORY TUBE OF EVAQUA CIRCUITS SUCH AS THE RT340 IS (B)(4), HOWEVER THE EVAQUA TUBING REMAINS MORE SUSCEPTIBLE TO DAMAGE THAN CONVENTIONAL CIRCUITS WHEN EXPOSED TO ROUGH HANDLING OR DAMAGE CAUSED BY SHARP OBJECTS AND CIRCUIT HANGERS. OUR USER INSTRUCTIONS ADVISE THE USER TO "FIT ONLY SUPPLIED FISHER & PAYKEL HEALTHCARE CIRCUIT HANGER WITH CARE TO AVOID CIRCUIT DAMAGE." THE RT340 USER INSTRUCTIONS INCLUDE THE FOLLOWING STATEMENT: "SET APPROPRIATE VENTILATOR ALARMS", AS VENTILATOR ALARMS ALERT THE USER TO A LEAK IN THE SYSTEM AND ALLOWS CAREGIVERS TO ACT BY REPLACING THE BREATHING CIRCUIT ACCORDING TO THEIR STANDARD PROCEDURES. IT ALSO ADVISE THE USER TO "FIT ONLY THE SUPPLIED FISHER & PAYKEL HEALTHCARE CIRCUIT HANGER WITH CARE TO AVOID CIRCUIT DAMAGE". (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE EXPIRATORY LIMB OF AN RT340 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT WAS "BROKEN". THE HOSPITAL HAS FURTHER REPORTED THAT "IT CAME IN CONTACT WITH SOMETHING". THIS WAS FOUND BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT340 110413

    Patients

    Seq Age Sex Outcome Treatment
    1