BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED BREATHING CIRCUIT

    MDR report key: 3356105 · Received September 18, 2013

    Report

    Report Number
    9611451-2013-00697
    Event Type
    Malfunction
    Date Received
    September 18, 2013
    Report Date
    August 23, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    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, AND WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED A HOLE IN THE EVAQUA (EXPIRATORY) LIMB OF THE BREATHING CIRCUIT. THE HOLE WAS FOUND 1CM FROM THE PATIENT END CONNECTOR. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 130515. CONCLUSION: BASED ON THE VISUAL INSPECTION, THE EVAQUA LIMB APPEARS TO HAVE BEEN PUNCTURED WITH A BLUNT OBJECT. ALL RT240 BREATHING CIRCUITS ARE VISUALLY INSPECTED AND PRESSURE TESTED FOR LEAKS BEFORE RELEASING FOR DISTRIBUTION. IN ADDITION, TUBE WEIGHING AND BOND STRENGTH TESTING IS PERFORMED EVERY 15 MINUTES. ANY BREATHING CIRCUIT WHICH FAILS ANY OF THESE TESTS IS DISCARDED. THIS SUGGESTS THAT THE SUBJECT BREATHING CIRCUIT WAS DAMAGED AFTER BEING RELEASED FOR DISTRIBUTION. THE HOSPITAL CORRECTLY FOLLOWED OUR USER INSTRUCTIONS AND IDENTIFIED THE FAULT DURING A LEAK TEST BEFORE USE ON A PATIENT. (B)(4). THE USER INSTRUCTIONS SUPPLIED WITH THE RT240 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 AN RT240 ADULT DUAL HEATED BREATHING CIRCUIT DID NOT PASS THE VENTILATOR LEAK TEST. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470178 ADULT DUAL HEATED BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT240 130515

    Patients

    Seq Age Sex Outcome Treatment
    1