BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 2232102 · Received September 1, 2011

    Report

    Report Number
    9611451-2011-00533
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Report Date
    August 15, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    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. THE 510(K) FOR THAT PRODUCT IS K983112. METHOD: THE COMPLAINT EVAQUA (EXPIRATORY) LIMB OF THE RT340 BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (FPH) (B)(4) AND VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED THAT AS THE EVAQUA LIMB WAS TAKEN OUT OF THE PACKAGING, THE FILM OF THE LIMB WAS BREAKING IN DIFFERENT LOCATIONS. CLOSER INSPECTION REVEALED THAT THE FILM, WHICH IS NORMALLY FLEXIBLE, WAS HARD AT THE AREAS WHERE IT SEPARATED. A LOT CHECK WAS NOT PERFORMED AS NO LOT NUMBER WAS PROVIDED. CONCLUSION: THE CAUSE OF THE REPORTED FAULT IS THE UNRAVELLING AND BREAKDOWN OF THE EVAQUA LIMB MATERIAL. ALTHOUGH THE CUSTOMER DID NOT PROVIDE ANY INFORMATION REGARDING THE TYPE OF DRUGS USED, IT IS KNOWN THAT THE USE OF TYLOXAPOL CAN CAUSE THE BREAKDOWN OF THE EVAQUA LIMB. ALL BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAKS PRIOR TO DISTRIBUTION. ANY BREATHING CIRCUIT WHICH DOES NOT PASS THE PRESSURE TEST IS DISCARDED. THE USER INSTRUCTIONS SUPPLIED WITH THE RT340 BREATHING CIRCUIT STATE: DO NOT USE MEDICATIONS CONTAINING TYLOXAPOL (SUCH AS TACHOLIQUIN) AS THIS MAY DAMAGE THE TUBING AND LEAD TO A LOSS OF VENTILATION PRESSURE; PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT; SET APPROPRIATE VENTILATOR ALARMS. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(4) REPORTED THAT A LEAK WAS HEARD FROM THE RT340 BREATHING CIRCUIT AND TWO HOLES WERE OBSERVED ON THE EXPIRATORY LIMB. 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