BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 3373022 · Received September 27, 2013

    Report

    Report Number
    9611451-2013-00732
    Event Type
    Malfunction
    Date Received
    September 27, 2013
    Date of Event
    August 22, 2013
    Report Date
    August 28, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    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. RESULTS: VISUAL INSPECTION REVEALED DAMAGE TO THE EVAQUA EXPIRATORY LIMB APPROXIMATELY 45 CM FROM THE DISTAL CONNECTOR. FURTHER DAMAGE WAS NOTED APPROXIMATELY 20 CM FROM THE DISTAL CONNECTOR. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 120810. CONCLUSION: BASED ON THE INSPECTION CONDUCTED, THE EVAQUA EXPIRATORY LIMB WAS MOST LIKELY PULLED APART. ALL RT340 BREATHING CIRCUITS ARE VISUALLY INSPECTED AND PRESSURE TESTED FOR LEAKS BEFORE RELEASING FOR DISTRIBUTION. ANY BREATHING CIRCUIT WHICH FAILS ANY OF THESE TESTS IS DISCARDED. IN ADDITION, TUBE WEIGHING AND BOND STRENGTH TESTING ARE PERFORMED EVERY (B)(4). IF ANY FAULTS ARE DETECTED THE WHOLE BATCH IS PLACED ON HOLD FOR INVESTIGATION. THIS SUGGESTS THAT THE SUBJECT BREATHING CIRCUIT WAS DAMAGED AFTER IT WAS RELEASED FOR DISTRIBUTION. FURTHERMORE, THE CUSTOMER WAS ABLE TO USE THE RETURNED BREATHING CIRCUIT FOR A DAY WITHOUT ANY ISSUES. (B)(4). THE USER INSTRUCTIONS SUPPLIED WITH THE RT340 BREATHING CIRCUIT STATE: "DO NOT STRETCH OR MILK THE TUBING." "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 HEALTHCARE FACILITY IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT THE EXPIRATORY LIMB OF AN RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT WAS DAMAGED. THIS WAS FOUND AFTER ONE DAY OF USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489446 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT340 120810

    Patients

    Seq Age Sex Outcome Treatment
    1