BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 4789928 · Received May 22, 2015

    Report

    Report Number
    9611451-2015-00245
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Date of Event
    March 31, 2015
    Report Date
    April 22, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K122432
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RT380 ADULT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (FPH) IN (B)(4) FOR INVESTIGATION. THE INSPIRATORY AND EXPIRATORY HEATER WIRE OF THE CIRCUIT WAS RESISTANCE TESTED USING A CALIBRATED MULTIMETER. RESULTS: THE RESISTANCE TEST REVEALED THAT THE INSPIRATORY AND EXPIRATORY HEATER WIRE ON THE RETURNED CIRCUIT WAS WITHIN SPECIFICATION. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 150304. CONCLUSION: FOLLOWING THIS INCIDENT, AN FPH REPRESENTATIVE VISITED THE HOSPITAL AND OBTAINED FURTHER INFORMATION AND OFFERED ADVICE TO ADDRESS THE REPORTED CONDENSATION ISSUE. THE FPH REPRESENTATIVE NOTICED THAT THE TEMPERATURE IN THE AFFECTED ROOM WAS 25 TO 27 DEGREES CELSIUS, WHICH IS VERY WARM. THIS TEMPERATURE IS AT THE UPPER END OF THE MR850 HUMIDIFIER OPERATING CONDITIONS OF 18 TO 26 DEGREES CELSIUS, STATED IN THE MR850 USER INSTRUCTION. A HIGH ROOM TEMPERATURE POTENTIALLY CAN CONTRIBUTE TO EXCESSIVE CONDENSATION, THUS ROOM TEMPERATURE MONITORING IS ESSENTIAL. CONDENSATE IN THE HUMIDIFICATION SYSTEM, 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 A NUMBER OF MULTIPLE SETUP AND ENVIRONMENTAL FACTORS. SINCE THE FPH REPRESENTATIVE VISITED THE HOSPITAL, WE HAVE RECEIVED NO FURTHER REPORTS RELATING TO CONDENSATION ISSUES. THE USER INSTRUCTIONS THAT ACCOMPANY THE MR850 STATE THE FOLLOWING: OPERATING CONDITIONS: RECOMMENDED AMBIENT TEMPERATURE 18 - 26 °C. CAUTION: IF OPERATING IN AMBIENT TEMPERATURES OUTSIDE THE RECOMMENDED RANGE, CONSULT YOUR LOCAL FISHER & PAYKEL HEALTHCARE REPRESENTATIVE OR CONSULT THE TECHNICAL MANUAL. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT380 STATE THE FOLLOWING: SET APPROPRIATE VENTILATOR ALARMS. CHECK BREATHING CIRCUITS FOR CONDENSATION EVERY 6 HOURS AND DRAIN IF REQUIRED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN INTUBATED PATIENT HAD BRONCHIAL CONGESTION ALLEGEDLY DUE TO CONDENSATION IN THE HUMIDIFICATION SYSTEM. CONDENSATION WAS NOTICED IN THE EXPIRATORY LIMB OF AN RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT. THE SUBJECT BREATHING CIRCUIT WAS USED IN CONJUNCTION WITH A DRAGER VENTILATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335933 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT380 150304

    Patients

    Seq Age Sex Outcome Treatment
    1 FISHER & PAYKEL HEALTHCARE MR850 HUMIDIFIER| DRAGER VENTILATOR