BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 2949397 · Received February 7, 2013

    Report

    Report Number
    9611451-2013-00082
    Event Type
    Malfunction
    Date Received
    February 7, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 10, 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) RETURNED BREATHING CIRCUITS: CIRCUITS 1-4, LOT: 120731; CIRCUITS 5-7, LOT: UNKNOWN. METHOD: SEVEN RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUITS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) AND WERE VISUALLY INSPECTED FOR THE REPORTED DAMAGE. THE INSPIRATORY AND EXPIRATORY LIMBS OF CIRCUIT 7 WERE CHECKED TO SEE IF THEY COULD BE CONNECTED TO A HEATER WIRE ADAPTOR. RESULTS: VISUAL INSPECTION REVEALED A HOLE IN THE EXPIRATORY LIMB IN THE FOLLOWING CIRCUITS: CIRCUIT 1: APPROXIMATELY 17CM FROM THE PROXIMAL CONNECTOR; CIRCUIT 2: APPROXIMATELY 27CM FROM THE PROXIMAL CONNECTOR; CIRCUIT 3: APPROXIMATELY 38CM FROM THE PROXIMAL CONNECTOR; CIRCUIT 4: APPROXIMATELY 48CM FROM THE PROXIMAL CONNECTOR; CIRCUIT 5: APPROXIMATELY 5.5CM FROM THE PROXIMAL CONNECTOR; CIRCUIT 6: APPROXIMATELY 11CM FROM THE PROXIMAL CONNECTOR; CIRCUIT 7: APPROXIMATELY 14CM FROM THE PROXIMAL CONNECTOR. THE HEATER WIRE ADAPTOR COULD NOT BE FULLY INSERTED TO THE INSPIRATORY AND EXPIRATORY LIMB HEATER WIRE PINS OF CIRCUIT 7. BOTH THE INSPIRATORY AND EXPIRATORY HEATER WIRE PINS WERE BENT AND OUT OF SPECIFICATION. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 120731. CONCLUSION: ALL BREATHING CIRCUITS ARE VISUALLY INSPECTED AND PRESSURE TESTED PRIOR TO LEAVING THE PRODUCTION FACILITY. ANY BREATHING CIRCUITS THAT FAIL ARE REJECTED. THIS SUGGESTS THAT THE LEAKS ON THE RETURNED RT340 BREATHING CIRCUITS DEVELOPED POST PRODUCTION. THE IDENTIFIED HOLES IN THE EXPIRATORY LIMBS WERE MOST LIKELY CAUSED BY A SCRATCH OR PUNCTURE BY A BLUNT OBJECT. THE KEY DIFFERENCE BETWEEN THE EVAQUA BREATHING CIRCUITS AND CONVENTIONAL BREATHING CIRCUITS IS THAT THE EXPIRATORY TUBE OF 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 NON-FPH CIRCUIT HANGERS. ALL BREATHING CIRCUITS ARE TESTED FOR CONNECTIVITY AND ELECTRICAL CONTINUITY DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. IT IS POSSIBLE FOR THE USER TO BEND OR SPLIT THE HEATER WIRE PINS IF THE HEATER WIRE ADAPTOR IS INSERTED INTO THE HEATER WIRE PLUG ON AN ANGLE. FOR BENT OR SPLIT PINS REPORTED TO US BY HEALTHCARE FACILITIES, IT IS IMPOSSIBLE FOR US TO DETERMINE WHETHER THE PINS WERE BENT OR SPLIT DURING PRODUCTION OR BY THE END USER. THE USER INSTRUCTIONS SUPPLIED WITH THE RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT STATE THE FOLLOWING: 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 TO OUR DISTRIBUTOR THAT SEVEN RT340 ADULT DUAL HEATED EVAQUA BREATHING CIRCUITS HAD HOLES IN THE EXPIRATORY LIMB. THEY FURTHER REPORTED THAT ONE OF THE CIRCUITS HAD BENT HEATER WIRE PINS. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51888 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT340 120731

    Patients

    Seq Age Sex Outcome Treatment
    1