BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BIAS FLOW BREATHING CIRCUIT

    MDR report key: 2741943 · Received September 12, 2012

    Report

    Report Number
    9611451-2012-00623
    Event Type
    Malfunction
    Date Received
    September 12, 2012
    Date of Event
    August 7, 2012
    Report Date
    August 15, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K020332
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: ONLY THE PRESSURE LINE OF THE COMPLAINT RT225 INFANT BIAS FLOW CIRCUIT KIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (FPH) IN (B)(4) AND WAS VISUALLY INSPECTED FOR THE MISSING CONNECTOR. RESULTS: VISUAL INSPECTION REVEALED THAT THE NEO PRESSURE ELBOW WAS MISSING FROM THE RETURNED PRESSURE LINE, CONFIRMING THE REPORTED FAULT. THE PRESSURE LINE DID NOT SHOW ANY EVIDENCE THAT THE ELBOW WAS EVER INSERTED. NO PHYSICAL DAMAGE WAS OBSERVED TO THE RETURNED PRESSURE LINE, WHICH WAS RECEIVED IN AN UNSEALED PLASTIC BAG. A LOT CHECK DID NOT REVEAL ANY COMPLAINTS OF THIS NATURE FOR LOT NUMBER 111221. CONCLUSION: IT IS LIKELY THAT OPERATOR ERROR, DURING THE ASSEMBLY PROCESS, RESULTED IN THE NEO PRESSURE ELBOW BEING OMITTED FROM THE PRESSURE LINE. THERE ARE STANDARD OPERATING PROCEDURES IN PLACE TO ASSIST OPERATORS ON THE PRODUCTION LINE TO CORRECTLY ASSEMBLE THE PRESSURE LINES. THE STANDARD OPERATING PROCEDURE FOR ASSEMBLING THE PRESSURE LINE INCLUDES STEP BY STEP INSTRUCTIONS IN PICTORIAL FORM ON HOW TO ASSEMBLE THE PRESSURE LINE ON TO THE NEO PRESSURE ELBOW. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO ONE OF OUR DISTRIBUTORS THAT THE ELBOW CONNECTOR WAS MISSING FROM THE PRESSURE LINE OF AN RT225 INFANT BIAS FLOW BREATHING CIRCUIT KIT. THIS WAS FOUND PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO ONE OF OUR DISTRIBUTORS THAT THE ELBOW CONNECTOR WAS MISSING FROM AN RT225 INFANT BIAS FLOW BREATHING CIRCUIT KIT. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT BIAS FLOW BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT225 111221

    Patients

    Seq Age Sex Outcome Treatment
    1