BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT CONTINUOUS FLOW BREATHING CIRCUIT

    MDR report key: 3340436 · Received September 10, 2013

    Report

    Report Number
    9611451-2013-00680
    Event Type
    Malfunction
    Date Received
    September 10, 2013
    Report Date
    August 12, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K020332
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE WAS RECENTLY RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. OUR INVESTIGATION IS CURRENTLY IN PROGRESS AND WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION. INVESTIGATION CURRENTLY IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RT330 INFANT BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. THE RETURNED RT330 CIRCUIT WAS VISUALLY INSPECTED AND THE RESISTANCE OF THE HEATER WIRE WAS CHECKED WITH A CALIBRATED MULTIMETER. IN ADDITION, WE ATTEMPTED TO REPLICATE THE REPORTED DAMAGE BY CARRYING OUT SIMULATIONS ON SAMPLE RT330 INFANT BREATHING CIRCUITS. THE SIMULATIONS INCLUDED PINCHING THE INSPIRATORY LIMB IN A VISE, COVERING THE INSPIRATORY LIMB WITH A CLOTH, RUNNING THE CIRCUIT WITH NO GAS FLOW AND HEATING THE INSPIRATORY LIMB WITH AN EXTERNAL HEAT SOURCE. RESULTS: VISUAL INSPECTION REVEALED THAT THE INSPIRATORY LIMB WAS DAMAGED BETWEEN 36 TO 45 CM FROM THE PROXIMAL CONNECTOR. IN ONE PARTICULAR SECTION OF THE INSPIRATORY LIMB THE INNER TUBE APPEARED TO BE DAMAGED, HOWEVER NO DAMAGE WAS NOTED TO THE OUTER TUBE. THE RESISTANCE TEST SHOWED THAT THE INSPIRATORY HEATER WIRE WAS WITHIN SPECIFICATION. FURTHERMORE, NO DAMAGE WAS NOTED TO THE HEATER WIRE INSULATION. IN ALL OUR SIMULATIONS WE WERE UNABLE TO REPLICATE THE DAMAGE OBSERVED ON THE RETURNED RT330 INFANT BREATHING CIRCUIT. THE HOSPITAL FURTHER REPORTED THAT THE MR850 RESPIRATORY HUMIDIFIER INCLUDED IN THE SETUP AT THE TIME OF THE REPORTED INCIDENT WAS PERFORMANCE TESTED AND NO FAULT WAS FOUND WITH THE MR850. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 130711. CONCLUSION: WE ARE UNABLE TO DETERMINE THE CAUSE OF THE OBSERVED DAMAGE ON THE RETURNED RT330 INFANT BREATHING CIRCUIT. ALL BREATHING CIRCUITS ARE PRESSURE AND LEAK TESTED PRIOR TO BEING RELEASED FOR DISTRIBUTION. ANY CIRCUITS THAT FAIL ARE REJECTED. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT330 STATE THE FOLLOWING: "PATIENT MONITORING IS RECOMMENDED." "CHECK ALL CONNECTIONS, CAPS AND/OR PLUGS ARE TIGHT BEFORE USE."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN RT330 INFANT OPTIFLOW CIRCUIT WAS DAMAGED DURING USE. NO PATIENT CONSEQUENCE REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6), REPORTED THAT AN RT330 INFANT OPTIFLOW CIRCUIT WAS DAMAGED DURING USE. NO PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453515 INFANT CONTINUOUS FLOW BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT330 130711

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4) RESPIRATORY HUMIDIFIER| MASIMO RAD7 PULSE OXIMETER