BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFANT BREATHING CIRCUIT

    MDR report key: 1824381 · Received September 2, 2010

    Report

    Report Number
    9611451-2010-00529
    Event Type
    Injury
    Date Received
    September 2, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 5, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT228 IS NOT SOLD IN THE USA, BUT IS SIMILAR TO A DEVICE THAT IS SOLD IN THE USA. THE 510(K) FOR THE SIMILAR DEVICE IS K020332. METHOD: THE COMPLAINT DEVICE WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION. OUR ANALYSIS IS THEREFORE BASED ON OUR THE DESCRIPTION OF EVENTS AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: AS THE COMPLAINT BREATHING CIRCUIT WAS NOT RETURNED FOR FURTHER INVESTIGATION, WE HAVE NOT BEEN ABLE TO EXAMINE OR CARRY OUT FURTHER INVESTIGATION WITH THE DEVICE. CONCLUSION: ALTHOUGH NOT PREFERRED, CONDENSATION IS AN EXPECTED SIDE EFFECT OF HEATED PASS-OVER HUMIDIFICATION SYSTEMS. THE AMOUNT OF CONDENSATE CAN BE INFLUENCED BY EQUIPMENT SET-UP, SETTINGS AND ENVIRONMENTAL FACTORS, AND MAY VARY BETWEEN LIGHT MISTING TO WATER DROPLETS THAT FORM ON THE WALL OF COOL BREATHING CIRCUIT TUBINGS. THE CUSTOMER HAD PREVIOUSLY USED EVAQUA CIRCUITS AND WAS NOT FAMILIAR WITH THE USE OF BREATHING CIRCUITS WITH A WATER TRAP. OUR FIELD REPRESENTATIVE PROVIDED TRAINING AND SUPPORT ABOUT SET-UP AND MONITORING OF BREATHING CIRCUITS WITH WATER TRAPS AND THIS SOLVED THE HOSPITAL'S EXCESSIVE CONDENSATION PROBLEM.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT A PREMATURE BABY "WAS GETTING A LOT OF WATER IN HER LUNGS" DUE TO CONDENSATION IN AN RT228 INFANT BREATHING CIRCUIT. WHEN THE SENIOR NURSE SAW WHAT WAS HAPPENING SHE IMMEDIATELY TOOK THE CHILD OFF THE RT228 AND PUT HER ON AN RT235 BREATHING CIRCUIT. THE PROBLEM WAS SOLVED AND THE CHILD HAD NO LASTING CONSEQUENCE. A FISHER & PAYKEL REPRESENTATIVE SUBSEQUENLTY VISITED THE HOSPITAL AND DISCOVERED THAT THE INFANT WAS LYING IN AN INCUBATOR WITH THE HEAD OF THE INCUBATOR ANGLED MUCH HIGHER THAT TNE LOWER END OF THE INCUBATOR, THUS ENABLING CONDENSATE TO FLOW TOWARDS THE INFANT INSTEAD OF AWAY. THE HOSPITAL HAD ONLY RECENTLY BEGUN USING THIS PARTICULAR CIRCUIT. FURTHER TRAINING HAS NOW BEEN CARRIED OUT WITH THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT228 100408

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R MR850 RESPIRATORY HUMIDIFIER| SLE 5000 VENTILATOR