BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 2723999 · Received September 2, 2012

    Report

    Report Number
    9611451-2012-00595
    Event Type
    Malfunction
    Date Received
    September 2, 2012
    Date of Event
    August 6, 2012
    Report Date
    August 7, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. THE COMPLAINT RT265 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT IS NOT EXPECTED TO BE RETURNED TO FPH FOR FURTHER INVESTIGATION. WE ARE CURRENTLY IN THE PROCESS OF OBTAINING FURTHER INFORMATION FROM THE HOSPITAL IN ORDER TO ASSIST US WITH THE ANALYSIS AND IDENTIFICATION OF A POSSIBLE ROOT CAUSE OF THE ALLEGED EVENTS AS REPORTED. WE WILL PROVIDE A FOLLOW UP REPORT ONCE WE HAVE RECEIVED FURTHER INFORMATION AND COMPLETED OUR ANALYSIS.

    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 FPH FOR EVALUATION. OUR INVESTIGATION IS ACCORDINGLY BASED ON THE EVENT DESCRIPTION AND ADDITIONAL INFORMATION PROVIDED BY THE HOSPITAL, AND OUR KNOWLEDGE OF THE PRODUCT. FOLLOWING RECEIPT OF THIS COMPLAINT, AN FPH REPRESENTATIVE CONTACTED THE HOSPITAL TO OBTAIN FURTHER INFORMATION REGARDING THE REPORTED EVENT. RESULTS: THE HOSPITAL REPORTED THAT THE RT265 BREATHING CIRCUIT WAS ATTACHED TO THE UNHEATED EXTENSION TUBE THAT IS INCLUDED IN THE RT265 BREATHING CIRCUIT KIT. THE INFANT WAS IN AN INCUBATOR WITH A TEMPERATURE SETTING OF APPROXIMATELY 27.5 DEGREES C. THE AMBIENT TEMPERATURE IN THE ROOM WAS BETWEEN 24 TO 25 DEGREES C, WITH NO DIRECT AIR FLOW OVER THE PATIENT AREA. THE HOSPITAL STAFF ALSO REPORTED TO THE FPH REPRESENTATIVE THAT THE CONDENSATE WAS OBSERVED WITHIN THE BLUE INSPIRATORY LIMB OF THE BREATHING CIRCUIT, AND WAS NOTED PRIOR TO THE INCIDENT OCCURRING. THE CONDENSATE WAS BEING MANAGED BY THE CLINICAL STAFF AT THE BEDSIDE. A LOT CHECK WAS NOT PERFORMED AS LOT INFORMATION WAS NOT PROVIDED. 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. THE UNHEATED EXTENSION TUBE IS INTENDED FOR USE WITH AN INCUBATOR, WHERE TEMPERATURES ARE BETWEEN 33 TO 39 DEGREES C. IN THIS CASE, THE LIKELY CAUSE OF THE REPORTED EXCESSIVE CONDENSATION WAS THE USE OF THE UNHEATED EXTENSION TUBE WITH AN INCUBATOR WITH TEMPERATURE OF 27.5 DEGREES C. OUR USER INSTRUCTIONS THAT ACCOMPANY THE RT265 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT ILLUSTRATE IN PICTORIAL FORMAT THE CORRECT SET-UP AND USE OF THE BREATHING CIRCUIT, INCLUDING THE UNHEATED EXTENSION TUBE. IT ALSO STATE: "CHECK BREATHING CIRCUITS FOR CONDENSATION EVERY 6 HOURS AND DRAIN IF REQUIRED." (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT "A BABY HAD EXCESSIVE RAIN OUT IN THE VENTILATOR TUBING AND SUFFERED A MAJOR CLINICAL DETERIORATION AS A RESULT". IT WAS FURTHER REPORTED THAT "THE EVENT WAS IDENTIFIED AS BEING SECONDARY TO THE USE OF THE EXTENSION TUBE" OF AN RT265 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT IN AN INCUBATOR, WHERE THE AMBIENT TEMPERATURE WAS LESS THAN 35 DEGREES C.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT "A (B)(6) HAD EXCESSIVE RAIN OUT IN THE VENTILATOR TUBING AND SUFFERED A MAJOR CLINICAL DETERIORATION AS A RESULT". IT WAS FURTHER REPORTED THAT "THE EVENT WAS IDENTIFIED AS BEING SECONDARY TO THE USE OF THE EXTENSION TUBE" OF AN RT265 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT IN AN INCUBATOR, WHERE THE AMBIENT TEMPERATURE WAS LESS THAN 35 DEGREES C.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization