BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 2651731 · Received July 11, 2012

    Report

    Report Number
    9611451-2012-00448
    Event Type
    Injury
    Date Received
    July 11, 2012
    Report Date
    June 12, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    REFER TO H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. MANUFACTURER NARRATIVE: THE HEALTHCARE FACILITY REPORTED THAT THE COMPLAINT RT265 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUITS HAD BEEN DESTROYED. WE ARE CURRENTLY IN THE PROCESS OF OBTAINING FURTHER INFORMATION FROM THE HEALTHCARE FACILITY 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. DEVICES NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    (B)(4). BACKGROUND: 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 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUITS THAT WERE REPORTEDLY USED ON FOUR (B)(6) WERE NOT RETURNED TO FPH FOR EVALUATION AND THE HEALTHCARE FACILITY HAS ADVISED THAT THEY WERE DESTROYED. OUR ANALYSIS IS ACCORDINGLY BASED ON THE DESCRIPTION OF EVENTS AND LIMITED ADDITIONAL INFORMATION PROVIDED BY THE HEALTHCARE FACILITY. INFORMATION PROVIDED BY THE HEALTHCARE FACILITY: THE HEALTHCARE FACILITY INITIALLY REPORTED THAT FOUR (B)(6) SUDDENLY DEVELOPED PULMONARY EMPHYSEMA WHILE USING THE RT265 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUITS WITH THE MR700 SERIES HUMIDIFIERS. FOLLOWING FURTHER ENQUIRIES FROM FPH, THE HEALTHCARE FACILITY ADVISED THAT ITS STAFF HAD MADE ADJUSTMENTS TO THE MR700 SERIES HUMIDIFIERS IN ORDER TO ADJUST THE AMOUNT OF HUMIDITY. IT IS NOT CLEAR EXACTLY WHAT ADJUSTMENTS WERE MADE, BUT IT WAS SUGGESTED THAT ONLY THE TEMPERATURE AT THE PATIENT END WAS CHANGED. THE HEALTHCARE FACILITY ALSO REPORTED THAT ITS STAFF OBSERVED BRONCHIAL SECRETIONS THAT THEY ATTRIBUTED TO "INADEQUATE RESPIRATORY GAS CONDITIONING", AND ADVISED THAT THE (B)(6) HAD NOT SHOWN SIGNS OF INFLAMMATION OR OTHER PRELIMINARY LUNG DAMAGE. THE HEALTHCARE FACILITY ALSO REPORTED TO FPH THAT ALL FOUR (B)(6) ARE NOW IN A STABLE CONDITION. FPH HAS ATTEMPTED TO OBTAIN FURTHER INFORMATION ABOUT THE REPORTED EVENT, BUT HAS BEEN UNABLE TO DO SO. MANUFACTURER'S COMMENTS: THE RT265 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT USER INSTRUCTIONS (USER INSTRUCTIONS) ILLUSTRATE IN PICTORIAL FORMAT THE CORRECT SET-UP AND USE OF THE BREATHING CIRCUIT KIT. IT ALSO SETS OUT THE TECHNICAL SPECIFICATIONS REQUIRED DURING USE OF THE BREATHING CIRCUIT. WE HAVE BEEN UNABLE TO CONFIRM WHETHER THE RT265 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT WAS USED IN ACCORDANCE WITH THE USER INSTRUCTIONS AND THE TECHNICAL SPECIFICATIONS. (B)(4). FPH REPRESENTATIVES HAVE PROVIDED TRAINING TO THE HEALTHCARE FACILITY STAFF TO RE-ITERATE THE CORRECT USE OF THE BREATHING CIRCUITS AND OVERALL EQUIPMENT SET-UP IN ACCORDANCE WITH THE USER INSTRUCTIONS, AND ARE PLANNING TO ROLL OUT MORE TRAINING. CONCLUSION: WITHOUT SUFFICIENT INFORMATION FROM THE HEALTHCARE FACILITY, WE ARE UNABLE TO CONCLUDE WHAT HAS CAUSED THE REPORTED PULMONARY EMPHYSEMA. HOWEVER, BASED ON THE LIMITED INFORMATION WE RECEIVED AND OUR KNOWLEDGE OF OUR PRODUCTS, WE CANNOT SEE ANY EVIDENCE TO SUGGEST THAT THE RT265 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUITS OR THE MR700 SERIES HUMIDIFIERS MALFUNCTIONED OR BECAME DEFECTIVE DURING USE, OR THAT THE USE OF THOSE DEVICES WAS RELATED TO THE REPORTED PULMONARY EMPHYSEMA OF THE (B)(6).

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT WHILE USING RT265 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUITS, FOUR (B)(6) WERE REPORTED TO HAVE DEVELOPED PULMONARY EMPHYSEMA. THE HEALTHCARE FACILITY ALSO STATED THAT THE COMPLAINT BREATHING CIRCUITS HAD BEEN DESTROYED.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT WHILE USING RT265 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUITS, FOUR NEONATES WERE REPORTED TO HAVE DEVELOPED PULMONARY EMPHYSEMA. NO FURTHER INFORMATION WAS RECEIVED REGARDING THIS INCIDENT. THE HEALTHCARE FACILITY ALSO STATED THAT THE COMPLAINT BREATHING CIRCUITS HAD BEEN DESTROYED.

    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 Other MR700 SERIES RESPIRATORY HUMIDIFIERS