BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED BREATHING CIRCUIT

    MDR report key: 4372206 · Received December 30, 2014

    Report

    Report Number
    9611451-2014-00950
    Event Type
    Malfunction
    Date Received
    December 30, 2014
    Report Date
    December 5, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), THE COMPLAINT RT240 CIRCUIT IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RT240 BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) AND WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED A HOLE APPROXIMATELY 5.5CM FROM THE PROXIMAL CONNECTOR ON THE EVAQUA EXPIRATORY LIMB. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 140625. CONCLUSION: BASED ON THE VISUAL INSPECTION, THE EVAQUA EXPIRATORY 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. 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 RT240 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 CAN BE MORE SUSCEPTIBLE TO DAMAGE THAN CONVENTIONAL CIRCUITS WHEN EXPOSED TO ROUGH HANDLING OR DAMAGE CAUSED BY SHARP OR BLUNT 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. THE HOSPITAL STAFF CORRECTLY CHECKED THE SUBJECT BREATHING CIRCUIT BEFORE PATIENT USE, WHICH IS IN LINE WITH OUR RT240 USER INSTRUCTIONS.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN RT240 ADULT DUAL HEATED BREATHING CIRCUIT HAD A HOLE IN THE EXPIRATORY LIMB.THIS WAS FOUND DURING THE VENTILATOR LEAK TEST, PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN RT240 ADULT DUAL HEATED BREATHING CIRCUIT HAD A HOLE IN THE EXPIRATORY LIMB. THIS WAS FOUND DURING THE VENTILATOR LEAK TEST, PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860393 ADULT DUAL HEATED BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT240 140625

    Patients

    Seq Age Sex Outcome Treatment
    1