BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 3361566 · Received September 21, 2013

    Report

    Report Number
    9611451-2013-00709
    Event Type
    Malfunction
    Date Received
    September 21, 2013
    Date of Event
    August 19, 2013
    Report Date
    August 23, 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
    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 A HOLE IN THE EVAQUA EXPIRATORY LIMB APPROXIMATELY 27 CM FROM THE PROXIMAL CONNECTOR ON THE RETURNED RT340 BREATHING CIRCUIT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 130403. CONCLUSION: BASED ON THE INSPECTION CONDUCTED, THE EVAQUA EXPIRATORY LIMB WAS MOST LIKELY PUNCTURED BY A BLUNT OBJECT. ALL RT340 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 AND THE WHOLE BATCH IS PLACED ON HOLD FOR INVESTIGATION. THIS SUGGESTS THAT THE SUBJECT 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." THE HOSPITAL CORRECTLY FOLLOWED OUR USER INSTRUCTIONS AND DETECTED THE REPORTED DAMAGE DURING THE SETUP CHECK AND BEFORE USE ON A PATIENT.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT A HOLE WAS FOUND ON THE EXPIRATORY LIMB OF AN RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT. THIS WAS FOUND DURING A VENTILATOR LEAK TEST AND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478630 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT340 130403

    Patients

    Seq Age Sex Outcome Treatment
    1