BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 3230643 · Received July 16, 2013

    Report

    Report Number
    9611451-2013-00535
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Report Date
    April 25, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    K103767
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE RETURNED DEVICES WERE VISUALLY INSPECTED. THE SUBJECT RT265 INFANT BREATHING CIRCUIT WAS RESISTANCE TESTED. IT WAS ALSO CONNECTED TO A WORKING MR850 RESPIRATORY HUMIDIFIER TO TEST FOR ALARM ACTIVATION. RESULTS: NO PHYSICAL DAMAGE WAS OBSERVED TO THE RETURNED DEVICES. THE RESISTANCE TEST SHOWED THAT THE RT265 INSPIRATORY HEATERWIRE WAS OPEN CIRCUIT, CAUSING THE ACTIVATION OF THE 'HEATERWIRE' ALARM WHEN THE SUBJECT RT265 INFANT BREATHING CIRCUIT WAS CONNECTED TO THE MR850 HUMIFIDIER. NO FAULT WAS FOUND WITH THE EXPIRATORY HEATERWIRE. A LOT CHECK WAS NOT PERFORMED AS LOT INFORMATION WAS NOT PROVIDED. CONCLUSION: ELECTRICAL OPEN CIRCUITS IN HEATERWIRES CAN BE ASSOCIATED WITH IMPROPER CRIMPING OF THE HEATERWIRE DURING PRODUCTION, SUCH THAT IT IS UNABLE TO PROVIDE CONTINUITY FOR THE FULL PERIOD OF USE. ALL RT265 BREATHING CIRCUITS ARE RESISTANCE TESTED DURING PRODUCTION, AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THE HEATERWIRE BECAME OPEN CIRCUIT AFTER THE SUBJECT RT265 WAS RELEASED FOR DISTRIBUTION, POSSIBLY AS A RESULT OF AN INTERMITTENT CRIMP CONNECTION. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT WHILE AN MR850JHU RESPIRATORY HUMIDIFIER WAS BEING USED WITH A PATIENT IN CONJUNCTION WITH THE MR290 AUTOFEED HUMIDIFICATION CHAMBER AND THE RT265 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT, A "WATER OUT" ALARM SOUNDED ON THE HUMIDIFIER; HOWEVER, IT WAS OBSERVED THAT THERE WAS SUFFICIENT WATER IN THE CHAMBER. NO PATIENT CONSEQUENCE WAS REPORTED AS A RESULT OF THIS INCIDENT. THE HOSPITAL RETURNED THE RT265 INFANT BREATHING CIRCUIT AND THREE MR290 CHAMBERS TO FPH FOR INSPECTION. UPON EVALUATION OF THE RT265 INFANT BREATHING CIRCUIT, IT WAS FOUND TO BE OPEN CIRCUIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330083 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT265 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 MR290 AUTOFEED HUMIDIFICATION CHAMBER| MR850JHU RESPIRATORY HUMIDIFIER