BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED BREATHING CIRCUIT

    MDR report key: 3260716 · Received August 2, 2013

    Report

    Report Number
    9611451-2013-00568
    Event Type
    Malfunction
    Date Received
    August 2, 2013
    Report Date
    July 5, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE CURRENTLY ATTEMPTING TO RETRIEVE THE COMPLAINT DEVICE. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4) METHOD: TWO COMPLAINT RT340 ADULT DUAL HEATED EVAQUA BREATHING CIRCUITS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE, ONE FROM LOT 120830 AND ONE WITH NO LOT NUMBER PROVIDED. THE CIRCUITS WERE VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED A HOLE IN THE EVAQUA (EXPIRATORY) LIMB OF BOTH BREATHING CIRCUITS. THE HOLE IN DEVICE 1 WAS 79CM FROM THE PROXIMAL CONNECTOR AND THE HOLE IN DEVICE 2 WAS 77CM FROM THE PROXIMAL CONNECTOR. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 120830. CONCLUSION: BASED ON THE VISUAL INSPECTION, THE SUBJECT EVAQUA LIMBS APPEARED 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 CIRCUITS WERE DAMAGED AFTER THEY WERE RELEASED FOR DISTRIBUTION. THE KEY DIFFERENCE BETWEEN FPH'S EVAQUA BREATHING CIRCUITS AND CONVENTIONAL BREATHING CIRCUITS IS THAT THE EXPIRATORY LIMB OF THE EVAQUA CIRCUITS SUCH AS THE RT340 IS COMPOSED OF A THIN, SEMI-PERMEABLE FILM SPECIALLY DESIGNED TO ALLOW WATER VAPOUR FROM EXPIRED VENTILATORY GAS TO PASS THROUGH. THE EVAQUA EXPIRATORY TUBE HAS A PROTECTIVE MESH WHICH PREVENTS DAMAGE TO THE WALLS OF THE TUBE, HOWEVER THE EVAQUA TUBING REMAINS MORE SUSCEPTIBLE TO DAMAGE THAN CONVENTIONAL CIRCUITS WHEN EXPOSED TO ROUGH HANDLING OR DAMAGE CAUSED BY SHARP OBJECTS AND NON-FPH CIRCUIT HANGERS. 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 PB840 VENTILATOR LEAK TEST. THIS WAS REPORTED PRIOR TO PATIENT USE.

    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 PB840 VENTILATOR LEAK TEST. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363637 ADULT DUAL HEATED BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT240 120830

    Patients

    Seq Age Sex Outcome Treatment
    1 PB840 VENTILATOR| PB840 VENTILATOR