BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 1933527 · Received December 20, 2010

    Report

    Report Number
    9611451-2010-00767
    Event Type
    Injury
    Date Received
    December 20, 2010
    Report Date
    November 29, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K034026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE ENDEAVOURING TO OBTAIN FURTHER INFORMATION REGARDING THE REPORTED EVENT AND PATIENT OUTCOME FROM THE HOSPITAL AND WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). WITHOUT THE COMPLAINT DEVICE WE ARE UNABLE TO REPLICATE THE SET UP TO DETERMINE THE ROOT CAUSE OF THE CONDENSATION OBSERVED BY THE CUSTOMER. OUR INVESTIGATION IS ACCORDINGLY BASED ON THE INFORMATION WE HAVE RECEIVED AND OUR KNOWLEDGE OF THE PRODUCT. CONDENSATE IN THE HUMIDIFICATION SYSTEM, ALTHOUGH NOT PREFERRED, IS 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 MULTIPLE SETUP AND ENVIRONMENTAL FACTORS. FPH HAS BEEN WORKING CLOSELY WITH THE HOSPITAL TO ENSURE THAT THEY SET UP THEIR SYSTEM PROPERLY AND ELIMINATE ANY ENVIRONMENTAL FACTORS THAT MAY CONTRIBUTE TO CONDENSATE IN THE SYSTEM. FPH IS ALSO WORKING WITH THE VENTILATOR MANUFACTURER, DRÄGER, AS THE HOSPITAL REPORTED THAT THEY BEGAN EXPERIENCING CONDENSATION ISSUES AFTER THEY BEGAN USING THE VN500 VENTILATOR. INCORRECT SET-UP WAS NOTICED DURING A HOSPITAL VISIT BY AN FPH REPRESENTATIVE. A TRAINING SESSION WITH HOSPITAL STAFF HAS ALSO BEEN COMPLETED AND FURTHER TRAINING SESSIONS HAVE BEEN ORGANISED. THE FPH REPRESENTATIVE HAS RECOMMENDED THE INSTALLATION OF 900MR303 RAIL MOUNTING BRACKETS, TO ALLOW THE MR850 HEATER BASE TO BE PLACED AT A LOWER POSITION, ALLOWING THE CONDENSATE TO DRAIN BACK INTO THE CHAMBER. FPH HAS BEEN WORKING CLOSELY WITH DRÄGER AND THE HOSPITAL WITH REGARD TO THIS REPORTED CONDENSATION COMPLAINT. THE FPH REPRESENTATIVE HAS REPORTED AN IMPROVEMENT IN CONDENSATION MANAGEMENT SINCE THEIR VISIT. THE HOSPITAL HAS FURTHER REPORTED THAT THE PATIENTS ARE DOING WELL.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) HAS REPORTED TO (B)(6) THAT THEY HAVE BEEN EXPERIENCING CONDENSATION ISSUES, WHERE PATIENTS HAVE INHALED WATER DROPLETS AND DESATURATED WHILE BEING TREATED WITH AN RT235 INFANT BREATHING CIRCUIT, AN MR850 RESPIRATORY HUMIDIFIER AND A NEW VENTILATOR, THE DRAGER VN500.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) HAS REPORTED TO (B)(4) AND (B)(4) THAT THEY HAVE BEEN EXPERIENCING CONDENSATION ISSUES, WHERE PATIENTS HAVE INHALED WATER DROPLETS AND DESATURATED WHILE BEING TREATED WITH AN RT235 INFANT BREATHING CIRCUIT, AN MR850 RESPIRATORY HUMIDIFIER AND A NEW VENTILATOR, THE DRAGER VN500.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT235

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DRAGER VN500 VENTILATOR| MR850 RESPIRATORY HUMIDIFIER| MR850 RESPIRATORY HUMIDIFIER| DRAGER VN500 VENTILATOR