BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BREATHING CIRCUIT

    MDR report key: 1181703 · Received September 30, 2008

    Report

    Report Number
    9611451-2008-00565
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Report Date
    August 8, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD.
    Product Code
    BTT
    PMA / PMN Number
    K020332
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES WERE NOT RETURNED TO THE MFR TO INVESTIGATION. AN INVESTIGATION WAS CARRIED OUT BASED ON THE EVENT DESCRIPTION AND PREVIOUS EXPERIENCE WITH SIMILAR COMPLAINTS. RESULTS: BREATHING CIRCUITS WITH HEATED INSPIRATORY AND EXPIRATORY TUBES HAVE DIFFERENT HEATERWIRE PLUGS FOR THE INSPIRATORY AND EXPIRATORY TUBES. A LOT CHECK REVEALED 10 OTHER COMPLAINTS OF THIS NATURE FOR THIS LOT NUMBER. CONCLUSION: AN INSPIRATORY TUBE WAS INCORRECTLY OVERMOLDED WITH AN EXPIRATORY PLUG DURING PRODUCTION. AN INVESTIGATION INTO THE PRODUCTION PROCESS REVEALED THAT THE OPERATOR MADE AN ERROR DURING PRODUCTION FOR APPROXIMATELY 2 HOURS. THE SIZE OF THE BATCH PRODUCED WAS NOT SIGNIFICANT. THE INCORRECT CIRCUIT PRODUCED CANNOT BE CONNECTED TO THE HUMIDIFIER. THIS IS EQUIVALENT TO AN OPEN CIRCUIT HEATERWIRE AND THE HUMIDIFIER WOULD ALARM, IN ADDITION TO THE USER DETECTING THIS ON SETUP. WERE ARE CURRENTLY MODIFYING OUR PRODUCTION PROCESS TO REDUCE OR PREVENT RECURRENCE OF THIS ISSUE. OUR MONITORING AND TRENDING OF INCORRECT HEATERWIRE PLUGS ON BREATHING CIRCUITS HAS A FEW RATE OF OCCURRENCE WORLDWIDE FOR THE LAST YEAR OF ALL UNITS SOLD.

    Description of Event or Problem · 1

    A HOSPITAL REPORTED VIA OUR DISTRIBUTOR THAT THE HEATED WIRE CONNECTION WAS REVERSED ON A QUANTITY OF INFANT BREATHING CIRCUITS. THEY REPORTED THE CONNECTION WAS A DUAL INSTEAD OF A TRI FIT. NO PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE LTD. RT329 080408

    Patients

    Seq Age Sex Outcome Treatment
    1