BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 2221126 · Received August 23, 2011

    Report

    Report Number
    9611451-2011-00514
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    July 29, 2011
    Report Date
    August 2, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    SEE H10
    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 COMPLAINT RT340 BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (FPH) (B)(4) FOR INSPECTION. THE EVAQUA (EXPIRATORY) LIMB WAS VISUALLY INSPECTED AND PERFORMANCE TESTED. A HOLE WAS FOUND IN THE RETURNED EVAQUA LIMB, APPROXIMATELY 12.5CM AWAY FROM THE CONNECTOR ON THE PATIENT END. 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 WAS NOT PERFORMED AS NO LOT NUMBER WAS PROVIDED. BASED ON INSPECTION OF THE HOLE, THE COMPLAINT EVAQUA EXPIRATORY LIMB OF THE BREATHING CIRCUIT WAS PUNCTURED OR SCRATCHED BY A BLUNT OBJECT. THE HOSPITAL HAS CONFIRMED THAT THEY WERE USING A NON-FPH CIRCUIT HANGER, WHICH IS NOT RECOMMENDED FOR USE WITH OUR EVAQUA CIRCUITS AND IS MOST LIKELY THE CAUSE OF THE OBSERVED DAMAGE. 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 COMPOSED OF (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. 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. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AIR LEAKED FROM THE EXPIRATORY LIMB OF AN RT340 BREATHING CIRCUIT AFTER THREE DAYS OF USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1