BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BIAS FLOW BREATHING CIRCUIT

    MDR report key: 2228109 · Received August 30, 2011

    Report

    Report Number
    9611451-2011-00531
    Event Type
    Malfunction
    Date Received
    August 30, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 2, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT225 INFANT BIAS FLOW BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IS SIMILAR TO A PRODUCT WHICH SOLD IN THE USA. THE 510(K) NUMBER OF THAT PRODUCT IS K20332. THE COMPLAINT DEVICE HAS ONLY RECENTLY BEEN RETURNED TO FISHER & PAYKEL HEALTHCARE AND IS CURRENTLY BEING INVESTIGATED. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE COMPLETED OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE ADAPTOR FROM THE COMPLAINT RT225 INFANT BREATHING CIRCUIT KIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) AND VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED THAT THE PVC TUBE ON THE ADAPTOR WAS CUT AND THE DETACHED PIECE OF PVC TUBE WAS APPROXIMATELY 16.5MM LONG. A LOT CHECK REVEALED NO OTHER COMPLAINT OF THIS TYPE FOR LOT NUMBER 110418. CONCLUSION: A FOOT SWITCH CONTROLS THE BLADE OF THE MACHINE WHICH CUTS THE PVC TUBING TO LENGTH. THE STANDARD OPERATING PROCEDURE (SOP) INVOLVING THE ASSEMBLY OF THE PVC TUBE AND ADAPTOR REQUIRES THE OPERATOR TO CHECK THAT THE PVC TUBE HAS BEEN FULLY INSERTED INTO THE ADAPTOR AFTER THE CUTTING PROCESS. IT IS POSSIBLE FOR THE OPERATOR TO PARTIALLY CUT THE PVC TUBE WHEN THE FOOT SWITCH IS ACCIDENTALLY DEPRESSED WHILE THE PVC TUBE IS NOT INSERTED TO ITS CORRECT CUTTING LENGTH, AND THIS WAS NOT IDENTIFIED DURING THE VISUAL CHECK PROCESS. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT AN RT225 INFANT BIAS FLOW BREATHING CIRCUIT HAD A "LATERAL CLEFT." THE HOSPITAL FURTHER REPORTED THAT THE "CLEAR TUBE OF THE VENT ADAPTOR CUT NATURALLY." THIS WAS FOUND PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT AN RT225 INFANT BIAS FLOW BREATHING CIRCUIT HAD A "LATERAL CLEFT". THIS WAS NOTICED PRIOR TO PATIENT USE. THE HOSPITAL FURTHER REPORTED THAT THE "CLEAR TUBE OF THE VENT ADAPTOR CUT NATURALLY". NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT BIAS FLOW BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT225 110418

    Patients

    Seq Age Sex Outcome Treatment
    1