BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 2851799 · Received November 29, 2012

    Report

    Report Number
    9611451-2012-00775
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    September 14, 2012
    Report Date
    September 27, 2012
    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). PLEASE NOTE AN INITIAL REPORT WAS SUBMITTED ON 26 OCTOBER 2012 WITH A FOLLOW UP DUE UPON COMPLETION OF OUR INVESTIGATION. DUE TO AN ERROR THE INITIAL REPORT WAS SUBMITTED VIA THE TEST GATEWAY. PLEASE CONSIDER THIS OUR INITIAL/FINAL REPORT FOR THIS COMPLAINT. RETURNED DEVICES: BREATHING CIRCUIT 1: LOT NUMBER 120620. BREATHING CIRCUIT 2: LOT NUMBER NOT PROVIDED. METHOD: THE COMPLAINT DEVICES WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. BOTH CIRCUITS WERE PERFORMANCE TESTED AND VISUALLY INSPECTED FOR THE REPORTED DAMAGE. RESULTS: BREATHING CIRCUIT 1: FULL INSERTION OF THE INSPIRATORY HEATER WIRE PINS WITH THE HEATER WIRE ADAPTOR WAS NOT ACHIEVED. ONE OF THE HEATER WIRE PINS WAS BENT AND OUT OF SPECIFICATION. FULL INSERTION OF THE EXPIRATORY HEATER WIRE PINS WITH THE HEATER WIRE ADAPTOR WAS ACHIEVED. BREATHING CIRCUIT 2: FULL INSERTION OF THE EXPIRATORY HEATER WIRE PINS WITH THE HEATER WIRE ADAPTOR WAS NOT ACHIEVED. ONE OF THE HEATER WIRE PINS WAS BENT AND OUT OF SPECIFICATION. FULL INSERTION OF THE INSPIRATORY HEATER WIRE PINS WITH THE HEATER WIRE ADAPTOR WAS ACHIEVED. VISUAL INSPECTION REVEALED A HOLE IN THE EXPIRATORY LIMB APPROXIMATELY 4.5 CM FROM THE PROXIMAL CONNECTOR. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 120620. CONCLUSION: 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 DURING USE 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. ALL BREATHING CIRCUITS ARE ALSO VISUALLY INSPECTED AND PRESSURE TESTED PRIOR TO LEAVING THE PRODUCTION FACILITY. ANY BREATHING CIRCUITS THAT FAIL ARE REJECTED. THIS SUGGESTS THAT THE HOLE IN THE EXPIRATORY LIMB DEVELOPED POST PRODUCTION. IT WAS MOST LIKELY CAUSED BY A SCRATCH OR PUNCTURE BY A BLUNT OBJECT. (B)(4). 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 TWO RT340 ADULT DUAL HEATED EVAQUA BREATHING CIRCUITS COULD NOT BE CONNECTED TO THE HEATER WIRE ADAPTOR. THEY FURTHER REPORTED THAT THE HEATER WIRE PINS WERE DAMAGED ON BOTH BREATHING CIRCUITS. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT340 120620

    Patients

    Seq Age Sex Outcome Treatment
    1