BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 3148163 · Received June 5, 2013

    Report

    Report Number
    9611451-2013-00442
    Event Type
    Malfunction
    Date Received
    June 5, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 7, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE

    Narratives

    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 FOR THE REPORTED DAMAGE. RESULTS: VISUAL INSPECTION REVEALED A HOLE APPROXIMATELY 6 CM FROM THE DISTAL CONNECTOR ON THE EVAQUA EXPIRATORY LIMB. A LOT CHECK REVEALED ONE OTHER COMPLIANT OF THIS NATURE FOR LOT NUMBER 120712. CONCLUSION: BASED ON THE INSPECTION OF THE DAMAGE, IT IS LIKELY THAT THE EVAQUA EXPIRATORY LIMB WAS PUNCTURED OR SCRATCHED BY A BLUNT OBJECT. ALL RT340 BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAKS PRIOR TO BEING RELEASED FOR DISTRIBUTION. (B)(4). ANY BREATHING CIRCUIT WHICH FAILS ANY OF THESE TESTS IS DISCARDED. THIS SUGGESTS THAT THE BREATHING CIRCUIT WAS DAMAGED AFTER IT WAS RELEASED FOR DISTRIBUTION. (B)(4). 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.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT THERE WAS AN AIR LEAK ON THE EXPIRATORY LIMB OF AN RT340 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248696 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT340 120712

    Patients

    Seq Age Sex Outcome Treatment
    1