BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 2855069 · Received December 3, 2012

    Report

    Report Number
    9611451-2012-00883
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 5, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K983112. METHOD: 2 COMPLAINT RT340 BREATHING CIRCUITS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE (FPH) (B)(4) FOR INSPECTION. THE INSPIRATORY AND EXPIRATORY LIMBS WERE PERFORMANCE TESTED. LOT NUMBER WAS NOT PROVIDED FOR THE FIRST RT340 DEVICE. SECOND RT340 DEVICE HAS A LOT NUMBER OF 120721. RESULTS: FIRST DEVICE (UNKNOWN LOT NUMBER): FULL INSERTION OF THE HEATER WIRE PINS OF THE EXPIRATORY LIMB WITH THE HEATER WIRE ADAPTOR WAS ACHIEVED, BUT FULL INSERTION OF THE HEATER WIRE PINS OF THE INSPIRATORY LIMB WITH THE HEATER WIRE ADAPTOR WAS NOT ACHIEVED. ONE OF THE HEATER WIRE PINS ON THE INSPIRATORY LIMB WAS FOUND TO BE BENT. SECOND DEVICE (LOT NUMBER 120721): VISUAL INSPECTION REVEALED THAT ONE COMPLAINT RT340 DEVICE HAD A HOLE ON THE EVAQUA LIMB, ABOUT 79 CM AWAY FROM THE PATIENT END CONNECTOR. FULL INSERTION OF THE HEATER WIRE PINS OF THE INSPIRATORY AND EXPIRATORY LIMBS WITH THE HEATER WIRE ADAPTOR WAS ACHIEVED. HEATER WIRE RESISTANCE TEST REVEALED THAT THE HEATER WIRE PINS OF THE INSPIRATORY AND EXPIRATORY LIMBS WERE WITHIN SPECIFICATIONS. A LOT CHECK REVEALED NO OTHER COMPLAINT OF THIS TYPE FOR LOT NUMBER 120721. 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. THE HOLE FOUND ON THE EVAQUA LIMB APPEARED TO HAVE BEEN CAUSED BY BEING PUNCTURED OR SCRATCHED WITH A BLUNT OBJECT. ALL RT340 BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAKS PRIOR TO DISTRIBUTION AND THOSE THAT FAIL ARE REJECTED. (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;

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT THE HEATER WIRE PINS OF TWO RT340 ADULT DUAL HEATED EVAQUA BREATHING CIRCUITS WERE DAMAGED. 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 120721

    Patients

    Seq Age Sex Outcome Treatment
    1