BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLOW JUNIOR INTERFACE

    MDR report key: 5171607 · Received October 23, 2015

    Report

    Report Number
    9611451-2015-00444
    Event Type
    Malfunction
    Date Received
    October 23, 2015
    Date of Event
    September 23, 2015
    Report Date
    September 25, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    CAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT OPT314 OPTIFLOW JUNIOR CANNULA WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN NEW ZEALAND WHERE IT WAS VISUALLY INSPECTED FOR THE REPORTED DAMAGE. RESULTS: VISUAL INSPECTION REVEALED THAT THE LEFT TUBE WAS DAMAGED APPROXIMATELY 125MM AND 130MM FROM THE BREATHING CIRCUIT CONNECTOR. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 150521. CONCLUSION: WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE DAMAGE OBSERVED ON THE RETURNED OPT314 CANNULA. HOWEVER, BASED ON OUR KNOWLEDGE OF PREVIOUS INVESTIGATIONS INTO THIS TYPE OF FAILURE MODE, IT IS LIKELY THAT THE TUBING WAS DAMAGED DUE TO EXCESSIVE FORCE BEING EXERTED ON THE TUBING. ALL OPTIFLOW JUNIOR CANNULAE ARE 100% LEAK AND OCCLUSION TESTED AFTER FINAL ASSEMBLY AND ANY CANNULA THAT FAILS IS DISCARDED. IN ADDITION, SAMPLES ARE CURRENTLY TAKEN HOURLY FROM EACH RUN AND PULL TESTED TO CHECK GLUE JOINT STRENGTH AT THE CANNULA/TUBE JOINT, AS WELL AS THE SWIVEL GRIP JOINT (CIRCUIT CONNECTOR). IF THERE ARE ANY FAILURES THE ENTIRE BATCH IS PLACED ON HOLD FOR FURTHER INVESTIGATION. THE USER INSTRUCTIONS ILLUSTRATE IN PICTORIAL FORM THE CORRECT SET-UP AND PROPER USE OF THE OPTIFLOW JUNIOR NASAL CANNULA. THEY ALSO STATE THE FOLLOWING: "DO NOT STRETCH OR CRUSH TUBE". "ENSURE THAT ALL CONNECTIONS ARE SECURE DURING USE. CHECK CANNULA IS UNDAMAGED AND THAT THE FLOW PATH IS MAINTAINED." "APPROPRIATE MONITORING MUST BE USED AT ALL TIMES."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) REPRESENTATIVE THAT THE TUBING ON AN OPT314 OPTIFLOW JUNIOR CANNULA WAS DAMAGED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701351 OPTIFLOW JUNIOR INTERFACE CAT CAT FISHER & PAYKEL HEALTHCARE LTD OPT314 150521

    Patients

    Seq Age Sex Outcome Treatment
    1