BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLOW JUNIOR INTERFACE

    MDR report key: 4686449 · Received April 13, 2015

    Report

    Report Number
    9611451-2015-00200
    Event Type
    Malfunction
    Date Received
    April 13, 2015
    Report Date
    March 20, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    CAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE OPTIFLOW JUNIOR CANNULA IS DESIGNED SPECIFICALLY FOR THE DELICATE ANATOMICAL FEATURES AND FLOW REQUIREMENTS OF NEONATAL AND PAEDIATRIC PATIENTS. IT FEATURES ADHESIVE PADS TO MAINTAIN CANNULA STABILITY ON THE PATIENT'S CHEEKS, SOFT-TOUCH NASAL PRONGS AND BREATHABLE KINK-PROOF AND CRUSH-RESISTANT FLEXIBLE TUBING. THE OPTIFLOW JUNIOR PROVIDES A REVOLUTIONARY STEP BETWEEN LOW-FLOW OXYGEN THERAPY AND CPAP. METHOD: THE COMPLAINT (B)(4) CANNULA WAS RECEIVED AT FISHER & PAYKEL HEALTHCARE (FPH) (B)(4). IN ADDITION TO THE COMPLAINT CANNULA THREE MORE UNUSED CANNULAE FROM THE SAME LOT AND (B)(6) CANNULAE FROM LOT 141006 (MANUFACTURE DATE 6 OCT 2014) WERE RECEIVED. IN ALL, (B)(6) CANNULAE WERE RECEIVED. THE RETURNED CANNULAE WERE VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION OF THE COMPLAINT CANNULA REVEALED THAT THE RIGHT FLEXITUBE WAS DAMAGED WHERE IT CONNECTS TO THE SWIVEL GRIP. THE TUBING WAS STRETCHED AND BROKEN BUT THE METAL SPRING WAS STILL ATTACHED. THE REMAINING (B)(6) UNUSED CANNULAE DID NOT HAVE ANY DAMAGE OR DEFECT AND NO FAULT WAS FOUND WITH ANY OF THEM. CONCLUSION: THE DAMAGE TO THE FLEXITUBE APPEARED TO HAVE BEEN CAUSED BY STRETCHING OR PULLING THE TUBE WITH EXCESSIVE FORCE. THE HOSPITAL HAS INFORMED US THAT THE CANNULA WAS USED ON A PARTICULARLY ACTIVE CHILD OF JUST OVER (B)(6) YEAR OLD. 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 OPT316 OPTIFLOW JUNIOR NASAL CANNULA CAME APART AT THE SWIVEL GRIP AFTER 36 HOURS OF USE ON A PATIENT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244616 OPTIFLOW JUNIOR INTERFACE CAT CAT FISHER & PAYKEL HEALTHCARE LTD OPT316 141001

    Patients

    Seq Age Sex Outcome Treatment
    1