BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLOW JUNIOR INTERFACE

    MDR report key: 4900906 · Received July 9, 2015

    Report

    Report Number
    9611451-2015-00307
    Event Type
    Malfunction
    Date Received
    July 9, 2015
    Date of Event
    June 10, 2015
    Report Date
    June 11, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    CAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT OP318 CANNULA WAS RETURNED TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION AND WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION OF THE RETURNED CANNULA REVEALED THAT BOTH FLEXITUBES (CANNULA TUBING) WERE DAMAGED WHERE THEY CONNECT TO THE BREATHING CIRCUIT. THE TUBING WAS STRETCHED AND BROKEN BUT THE METAL SPRING WAS STILL ATTACHED. CONCLUSION: WE WERE UNABLE TO DETERMINE WHAT HAD CAUSED THE DAMAGE TO THE FLEXITUBES, BUT IT WAS LIKELY CAUSED BY EXCESS PULLING 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. IF THERE ARE ANY FAILURES THE ENTIRE BATCH IS PUT ASIDE FOR FURTHER INVESTIGATION. THE USER INSTRUCTIONS ILLUSTRATE IN PICTORIAL FORMAT THE CORRECT SET-UP AND PROPER USE OF THE OPTIFLOW JUNIOR NASAL CANNULA. THEY ALSO STATE THE FOLLOWING: - 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. - DO NOT STRETCH OR CRUSH TUBE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN OPT318 OPTIFLOW JUNIOR NASAL CANNULA TUBING WAS SEPARATING FROM THE SWIVEL GRIP AND CAUSING LEAK. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448114 OPTIFLOW JUNIOR INTERFACE CAT CAT FISHER & PAYKEL HEALTHCARE LTD OPT318

    Patients

    Seq Age Sex Outcome Treatment
    1