BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLOW JUNIOR TUBING KIT

    MDR report key: 4962581 · Received August 3, 2015

    Report

    Report Number
    9611451-2015-00338
    Event Type
    Malfunction
    Date Received
    August 3, 2015
    Date of Event
    July 8, 2015
    Report Date
    July 10, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K020332
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE INSPIRATORY LIMB, MR290 HUMIDIFICATION CHAMBER, PRESSURE RELIEF VALVE, AND OPT316 OPTIFLOW JUNIOR NASAL CANNULA WERE RETURNED TO FPH IN (B)(6). THE RETURNED DEVICES WERE VISUALLY INSPECTED. THE ELECTRICAL RESISTANCE OF THE INSPIRATORY HEATERWIRE WAS CHECKED USING A CALIBRATED MULTIMETER. RESULTS: VISUAL INSPECTION REVEALED THAT THERE WAS CONDENSATE IN THE INSPIRATORY LIMB. PATIENT SECRETIONS WERE OBSERVED ON THE OPT316 NASAL CANNULA, LOOP PADS AND TUBING. THE ELECTRICAL RESISTANCE TEST RESULT WAS WITHIN SPECIFICATION. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 150603. CONCLUSION: WE ARE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE EXCESSIVE CONDENSATION REPORTED BY THE HOSPITAL. 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 SET-UP AND ENVIRONMENTAL FACTORS. OUR USER INSTRUCTIONS INDICATE IN PICTORIAL FORMAT THE CORRECT SET-UP AND PROPER USE OF THE RT330 OPTIFLOW JUNIOR TUBING KIT, AND STATE THE FOLLOWING: - "CHECK THAT ALL CONNECTIONS, CAPS AND/OR PLUGS ARE TIGHT BEFORE USE." - "PATIENT MONITORING IS RECOMMENDED." - "WHEN MOUNTING A HUMIDIFIER ADJACENT TO A PATIENT ENSURE THAT THE HUMIDIFIER IS ALWAYS POSITIONED LOWER THAN THE PATIENT."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT EXCESSIVE CONDENSATION WAS OBSERVED IN THE INSPIRATORY TUBE OF AN RT330 OPTIFLOW JUNIOR TUBING KIT. THIS WAS OBSERVED DURING USE ON A PATIENT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505847 OPTIFLOW JUNIOR TUBING KIT BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED RT330 150603

    Patients

    Seq Age Sex Outcome Treatment
    1