BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIFLOW NASAL CANNULA

    MDR report key: 2773012 · Received October 4, 2012

    Report

    Report Number
    9611451-2012-00706
    Event Type
    Injury
    Date Received
    October 4, 2012
    Date of Event
    September 2, 2012
    Report Date
    September 6, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    CAT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE IS EN ROUTE TO THE MANUFACTURER. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIVING THE TWO COMPLAINT CANNULAS, IT WAS IDENTIFIED THAT ONE COMPLAINT CANNULA WAS OPT546 (LOT 120326) AND THE OTHER OPT544 (LOT 120514), INSTEAD OF TWO OPT546 (LOT 120326) OPTIFLOW NASAL CANNULAS ORIGINALLY REPORTED BY THE CUSTOMER. OPTIFLOW NASAL CANNULA IS USED TO DELIVER HUMIDIFIED OXYGEN TO PATIENTS. IT CONSISTS OF A LIGHTWEIGHT DELIVERY TUBE WHICH IS CONNECTED TO A RIGID PLASTIC BASE AND SOFT NASAL PRONGS (NASAL INTERFACE). THE INTERFACE IS HELD IN PLACE BY A HEAD STRAP AND ALSO INCLUDES A LANYARD WHICH IS PLACED AROUND THE PATIENT'S NECK OR ATTACHED TO THE PATIENT'S CLOTHING OR BEDDING TO REMOVE THE LOAD OF THE BREATHING CIRCUIT FROM THE PATIENT'S NARES. OPT546 AND OPT544 ARE BOTH OPTIFLOW NASAL CANNULAS, WHEREBY THE OPT546 IS OF A LARGE SIZE AND OPT544 IS A MEDIUM SIZE. DEVICE MANUFACTURER DATE - OPT546 LOT 120326 - 03-26-2012; OPT544 LOT 120514 - 05-14-2012. METHOD: TWO COMPLAINT OPTIFLOW NASAL CANNULAS WERE RETURNED TO THE MANUFACTURER AND VISUALLY INSPECTED. RESULTS: OPT546 (LOT 120326) - THE VISUAL INSPECTION REVEALED THAT THE DELIVERY TUBING HAD BEEN PULLED APART. OPT544 (LOT 120514) - THE VISUAL INSPECTION IDENTIFIED THAT THE GRIP HAD BEEN PARTLY PULLED OFF THE CONNECTOR. THE DELIVERY TUBING WAS FOUND TO BE PARTLY PULLED OFF THE CANNULA MANIFOLD, AND THE MANIFOLD WAS NOT FULLY SEATED IN THE NASAL INTERFACE. A LOT CHECK REVEALED ONE OTHER SIMILAR COMPLAINT OF THIS NATURE FOR LOT 120326. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 120514. CONCLUSION: IT IS POSSIBLE THAT THE DAMAGE OBSERVED TO THE RETURNED OPT546 CANNULA WAS CAUSED BY PULLING ON THE TUBE BY THE PATIENT OR HOSPITAL STAFF. THE DAMAGE OBSERVED ON THE RETURNED OPT544 CANNULA APPEARS TO HAVE BEEN PULLED WITH EXCESSIVE FORCE. THE OPTIFLOW NASAL CANNULA IS SHIPPED TO THE CUSTOMER FULLY ASSEMBLED WITH THE NASAL PRONGS FIRMLY SEATED ON THE PLASTIC MANIFOLD. THE INTERFACE IS 100% INSPECTED BY PRODUCTION LINE STAFF DURING ASSEMBLY FOR VISUAL DEFECTS SUCH AS CRACKS, TEARS, INCLUSIONS, DISCOLOURATION, STRETCHING AND DEFORMATION. IF ANY ARE FOUND THE INTERFACE IS REJECTED. OUR USER INSTRUCTIONS THAT ACCOMPANY BOTH OPT546 AND OPT544 STATE THE FOLLOWING: "DO NOT CRUSH OR STRETCH TUBE"

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN OPT546 OPTIFLOW NASAL CANNULA HAD A "HOLE" IN IT. THIS WAS NOTICED "IMMEDIATELY" AFTER IT WAS CONNECTED TO A PATIENT. A NEW OPT544 CANNULA WAS USED AND IT WAS REPORTED THAT AFTER FOUR DAYS OF USE PATIENT DESATURATION WAS OBSERVED, AND A "SMALL HOLE" WAS SUBSEQUENTLY NOTICED IN THE FLEXIBLE TUBING. THE HOSPITAL HAS FURTHER REPORTED THAT THE PATIENT IS FINE AND STILL USING THE OPTIFLOW. UPON RECEIPT OF THE NASAL CANNULAS IT WAS IDENTIFIED THAT THE CUSTOMER HAD RETURNED ONE OPT546 AND ONE OPT544. OPT546 AND OPT544 ARE BOTH OPTIFLOW NASAL CANNULAS, WHEREBY THE TWO DIFFER IN SIZES.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN OPT546 OPTIFLOW NASAL CANNULA HAD A "HOLE" IN IT. THIS WAS NOTICED "IMMEDIATELY" AFTER IT WAS CONNECTED TO A PATIENT. A NEW OPT546 CANNULA WAS USED AND IT WAS REPORTED THAT AFTER FOUR DAYS OF USE PATIENT DESATURATION WAS OBSERVED, AND A "SMALL HOLE" WAS SUBSEQUENTLY NOTICED IN THE FLEXIBLE TUBING. THE HOSPITAL HAS FURTHER REPORTED THAT THE PATIENT IS FINE AND STILL USING THE OPTIFLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIFLOW NASAL CANNULA CAT CAT FISHER & PAYKEL HEALTHCARE LTD OPT546 SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention