BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 2622074 · Received June 19, 2012

    Report

    Report Number
    9611451-2012-00401
    Event Type
    Injury
    Date Received
    June 19, 2012
    Date of Event
    May 17, 2012
    Report Date
    May 21, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT265 INFANT DUAL-HEATED EVAQUA2 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 K034026. METHOD: THE COMPLAINT BREATHING CIRCUIT WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION AS IT HAD BEEN DISCARDED BY THE HOSPITAL. OUR INVESTIGATION IS ACCORDINGLY BASED ON THE INFORMATION OBTAINED FROM THE HOSPITAL AND OUR KNOWLEDGE OF THE PRODUCT. FOLLOWING RECEIPT OF THIS COMPLAINT, CLINICAL AND PRODUCT DEVELOPMENT REPRESENTATIVES FROM FISHER & PAYKEL HEALTHCARE VISITED THE HOSPITAL TO OFFER ASSISTANCE AND TO OBTAIN FURTHER INFORMATION REGARDING THE REPORTED EVENT. RESULTS: THE HOSPITAL HAD INFORMED US THAT THE RT265 BREATHING CIRCUIT WAS ATTACHED TO THE 30CM UNHEATED EXTENSION THAT IS SUPPLIED WITH THE RT265 KIT. THE UNHEATED EXTENSION IS INTENDED FOR USE WITH AN INCUBATOR. THE INFANT WAS ON A DRÄGER BABYLOG 8000 VENTILATOR, USING SIPPV (SYNCHRONISED INTERMITTENT POSITIVE VENTILATION), AT A STANDARD FLOW OF 6 L/MIN. THE AMBIENT TEMPERATURE IN THE ROOM WAS AROUND 24-25 DEGREES C. IN ADDITION, THERE WERE TWO AIR CONDITIONING VENTS IN THE ROOM, BUT NO OPEN WINDOWS. THE INFANT WAS IN AN UNHEATED COT AT THE TIME OF THE EVENT. CONCLUSION: CONDENSATE IN THE HUMIDIFICATION SYSTEM CAN BE AN EXPECTED SIDE EFFECT OF HEATED PASS-OVER HUMIDIFICATION SYSTEMS IN MANY CONDITIONS, AND MAY VARY BETWEEN LIGHT MISTING TO WATER DROPLETS THAT FORM ON THE WALL OF COOL BREATHING CIRCUIT TUBING. THE AMOUNT OF CONDENSATE IN THE VENTILATION SYSTEM IS INFLUENCED BY A NUMBER OF MULTIPLE SETUP AND ENVIRONMENTAL FACTORS. IN THIS CASE THE LIKELY CAUSE OF THE EXCESSIVE CONDENSATION WAS THE USE OF THE UNHEATED CIRCUIT EXTENSION WITH AN UNHEATED COT. OUR USER INSTRUCTIONS SHOW THAT THE UNHEATED EXTENSION IS FOR USE IN AN INCUBATOR, WHERE TEMPERATURES ARE BETWEEN 33 AND 39 DEGREES C. THE AIR CONDITIONING VENTS COULD ALSO HAVE CAUSED COOL AIR TO BLOW ON THE BREATHING CIRCUIT. ANY OR ALL OF THESE FACTORS WOULD CAUSE THE AIR TO COOL AS IT PASSED FROM THE HEATED INSPIRATORY TUBE INTO THE UNHEATED EXTENSION. THERE WOULD HAVE BEEN A LARGE ENOUGH DROP IN TEMPERATURE TO ALLOW DEWPOINT TO BE REACHED AND CONDENSATION TO FORM. IT MUST ALSO BE NOTED THAT OPTIMAL PLACEMENT OF THE BREATHING CIRCUIT SHOULD HAVE ENSURED THAT CONDENSATION FROM THE BREATHING CIRCUIT DID NOT ENTER THE INFANT: OUR USER INSTRUCTIONS SHOW PROPER PLACEMENT OF THE BREATHING CIRCUIT RELATIVE TO THE BABY. OUR USER INSTRUCTIONS THAT ACCOMPANY THE RT265 ALSO STATE: "CHECK BREATHING CIRCUITS FOR CONDENSATION EVERY 6 HOURS AND DRAIN IF REQUIRED." SINCE THIS EVENT, REPRESENTATIVES FROM FISHER & PAYKEL HEALTHCARE CONTINUE TO WORK WITH THE HOSPITAL TO HELP THEM BETTER MANAGE ANY CONDENSATION ISSUES THAT MAY ARISE. WE HAVE HAD NO FURTHER EVENTS OF THIS NATURE REPORTED TO US SINCE THIS COMPLAINT.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT WHILE AN RT265 INFANT BREATHING CIRCUIT WAS BEING USED ON A PREMATURE INFANT A "LARGE AMOUNT OF WATER" ACCUMULATED IN THE INSPIRATORY TUBING AND WAS INHALED BY THE INFANT. THE HOSPITAL FURTHER REPORTED THAT THE INFANT SUFFERED SIGNIFICANT BRADYCARDIA AND DESATURATION AND REQUIRED SUCTIONING, RESUSCITATION AND REINTUBATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT265

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention