BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 17358461 · Received July 20, 2023

    Report

    Report Number
    9611451-2023-00589
    Event Type
    Malfunction
    Date Received
    July 20, 2023
    Date of Event
    March 15, 2022
    Report Date
    June 21, 2023
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K103767
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CORRECTED DATA: SECTION D1 BRAND NAME: INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT. SECTION D2 COMMON DEVICE NAME: BZE, PRODUCT CODE: BZE. SECTION G4 PREMARKET IDENTIFICATION PMA/510(K): K103767. SECTION H5. LABELED FOR SINGLE USE? YES. METHOD: THE UNSPECIFIED DUAL LIMB BREATHING CIRCUIT WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE (F&P) FOR EVALUATION. OUR INVESTIGATION IS THUS BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: THE HEALTHCARE FACILITY REPORTED THAT THE INSPIRATORY DRYLINE AND EXPIRATORY LIMB OF AN UNSPECIFIED DUAL LIMB BREATHING CIRCUIT WAS INCORRECTLY CONNECTED IN REVERSE AT THE VENTILATOR END. THIS WOULD RESULT IN THE PATIENT RECEIVING GAS FLOW THAT HAS NOT BEEN HUMIDIFIED BY THE MR850 RESPIRATORY HUMIDIFIER AS THE GAS HAS NOT PASSED THROUGH THE HUMIDIFICATION CHAMBER. THE HEALTHCARE FACILITY REPORTED THAT THE MR850 RESPIRATORY HUMIDIFIER ALARMED INTERMITTENTLY (THE ALARM TYPE WAS NOT SPECIFIED) OVER A PERIOD OF APPROXIMATELY 7 HOURS BEFORE THE MISCONNECTION WAS IDENTIFIED AND RESOLVED. IT WAS FURTHER REPORTED BY THE HEALTHCARE FACILITY THAT THE THAT THE TOTAL PERIOD OF REVERSE FLOW WAS 12 HOURS AND THAT BY THE TIME THE MISCONNECTION WAS RESOLVED THE PATIENT'S CONDITION HAD DETERIORATED WITH WORSENING GASES AND INCREASED OXYGEN REQUIREMENT. THERE WERE NO FURTHER REPORTED PATIENT CONSEQUENCES AFTER THE SET-UP WAS CORRECTED. CONCLUSION: THE REPORTED REVERSED CONNECTION OF THE INSPIRATORY DRYLINE AND EXPIRATORY LIMB AT THE VENTILATOR END WAS DUE TO A USER ERROR. IN THIS INSTANCE, THE PATIENT CONTINUED TO RECEIVE GAS FLOW, HOWEVER NO HUMIDITY WAS PROVIDED. THE USER INSTRUCTIONS THAT ACCOMPANY OUR DUAL LIMB BREATHING CIRCUIT SHOW IN PICTORIAL FORMAT THE CORRECT SET-UP OF THE SYSTEM, INCLUDING ARROWS INDICATING THE FLOW OF GAS VIA THE INSPIRATORY LIMB FROM THE VENTILATOR, THROUGH THE HUMIDIFIER, TO THE PATIENT AND RETURNED TO THE VENTILATOR VIA THE EXPIRATORY LIMB. THE USER INSTRUCTIONS ALSO INCLUDE THE FOLLOWING WARNINGS AND CAUTIONS: "APPROPRIATE PATIENT MONITORING (E.G. OXYGEN SATURATION) MUST BE USED AT ALL TIMES. FAILURE TO MONITOR THE PATIENT (E.G. IN THE EVENT OF AN INTERRUPTION TO GAS FLOW) MAY RESULT IN SERIOUS HARM, OR DEATH". "ENSURE APPROPRIATE VENTILATOR OR FLOW SOURCE ALARMS ARE SET BEFORE CONNECTING BREATHING SET TO PATIENT". "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT".

    Additional Manufacturer Narrative · 0

    (B)(4). WE ARE CURRENTLY IN THE PROCESS OF OBTAINING FURTHER INFORMATION ON THE REPORTED EVENT AND PATIENT CONSEQUENCE WAS REQUESTED. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN NOTTINGHAM REPORTED THAT THE INSPIRATORY DRYLINE AND EXPIRATORY LIMB OF AN UNSPECIFIED DUAL LIMB BREATHING CIRCUIT WAS INCORRECTLY CONNECTED IN REVERSE AT THE VENTILATOR END. THIS WOULD RESULT IN THE PATIENT RECEIVING GAS FLOW THAT HAS NOT BEEN HUMIDIFIED BY THE MR850 RESPIRATORY HUMIDIFIER AS THE GAS HAS NOT PASSED THROUGH THE HUMIDIFICATION CHAMBER. THE HEALTHCARE FACILITY REPORTED THAT THE MR850 RESPIRATORY HUMIDIFIER ALARMED INTERMITTENTLY (THE ALARM TYPE WAS NOT SPECIFIED) OVER A PERIOD OF APPROXIMATELY 7 HOURS BEFORE THE MISCONNECTION WAS IDENTIFIED AND RESOLVED. IT WAS FURTHER REPORTED BY THE HEALTHCARE FACILITY THAT THE THAT THE TOTAL PERIOD OF REVERSE FLOW WAS 12 HOURS AND THAT BY THE TIME THE MISCONNECTION WAS RESOLVED THE PATIENT'S CONDITION HAD DETERIORATED WITH WORSENING GASES AND INCREASED OXYGEN REQUIREMENT. THERE WERE NO FURTHER REPORTED PATIENT CONSEQUENCES AFTER THE SET-UP WAS CORRECTED.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE INSPIRATORY DRYLINE AND EXPIRATORY LIMB OF AN UNSPECIFIED DUAL LIMB BREATHING CIRCUIT WAS INCORRECTLY CONNECTED IN REVERSE AT THE VENTILATOR END. THIS WOULD RESULT IN THE PATIENT RECEIVING GAS FLOW THAT HAS NOT BEEN HUMIDIFIED BY THE MR850 RESPIRATORY HUMIDIFIER AS THE GAS HAS NOT PASSED THROUGH THE HUMIDIFICATION CHAMBER. THE HEALTHCARE FACILITY REPORTED THAT THE MR850 RESPIRATORY HUMIDIFIER ALARMED INTERMITTENTLY (THE ALARM TYPE WAS NOT SPECIFIED) OVER A PERIOD OF APPROXIMATELY 7 HOURS BEFORE THE MISCONNECTION WAS IDENTIFIED AND RESOLVED. IT WAS FURTHER REPORTED BY THE HEALTHCARE FACILITY THAT THE THAT THE TOTAL PERIOD OF REVERSE FLOW WAS 12 HOURS AND THAT BY THE TIME THE MISCONNECTION WAS RESOLVED THE PATIENT'S CONDITION HAD DETERIORATED WITH WORSENING GASES AND INCREASED OXYGEN REQUIREMENT. THERE WERE NO FURTHER REPORTED PATIENT CONSEQUENCES AFTER THE SET-UP WAS CORRECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100654 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT266 NOT PROVIDED
    1803428 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT266 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown DRAEGER BABYLOG VN500 VENTILATOR| DRAEGER BABYLOG VN500 VENTILATOR| F&P MR850 RESPIRATORY HUMIDIFIER| F&P MR850 RESPIRATORY HUMIDIFIER