BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 3054203 · Received April 11, 2013

    Report

    Report Number
    9611451-2013-00267
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 15, 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 WHERE IT WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED A HOLE APPROXIMATELY 11 CM FROM THE PROXIMAL CONNECTOR ON THE EVAQUA EXPIRATORY LIMB. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT NUMBER 121008. 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 DISTRIBUTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THAT THE BREATHING CIRCUIT WAS DAMAGED POST-PRODUCTION. (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 TO 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
    155879 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT340 121008

    Patients

    Seq Age Sex Outcome Treatment
    1