BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLOW NASAL CANNULA

    MDR report key: 4233792 · Received November 6, 2014

    Report

    Report Number
    9611451-2014-00850
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Report Date
    October 10, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    CAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT OPT544 OPTIFLOW NASAL CANNULAE (1 FROM LOT 131015, 1 FROM LOT 1405080302, MANUFACTURED ON 8 MAY 2014, AND 1 WITH LOT UNKNOWN) WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) AND WERE VISUALLY INSPECTED. RESULTS: TWO OF THE THREE OPTIFLOW NASAL CANNULAS WERE SEALED AND VISUAL INSPECTION REVEALED NO VISIBLE DAMAGE TO THESE CANNULAS. ONE CANNULA, LOT UNKNOWN, WAS FOUND TO BE DAMAGED. HOLES HAD FORMED IN THE EVAQUA FILM OF THE TUBING. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 131015 AND LOT 140508. CONCLUSION: WE WERE UNABLE TO DETERMINE WHAT HAD CAUSED THE DAMAGE TO THE SUBJECT CANNULA. HOWEVER, BASED ON THE INSPECTION CONDUCTED, THE DAMAGE TO THE TUBING COULD HAVE BEEN CAUSED BY ROUGH HANDLING OR CONTACT WITH HARSH CLEANING CHEMICALS. THE OPT544 INTERFACE IS USED TO DELIVER HUMIDIFIED OXYGEN TO PATIENTS. THE OPT544 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. THE OPT544 INTERFACE IS SHIPPED TO THE CUSTOMER FULLY ASSEMBLED. THE CANNULA IS 100% INSPECTED BY PRODUCTION LINE STAFF DURING ASSEMBLY FOR VISUAL DEFECTS SUCH AS CRACKS, TEARS, INCLUSIONS, DISCOLOURATION AND DEFORMATION. IF ANY ARE FOUND THE PRODUCT IS DISCARDED. OUR USER INSTRUCTIONS THAT ACCOMPANY THE OPT544 ILLUSTRATE THE PROCEDURE FOR FITTING THE OPTIFLOW NASAL CANNULA TO A PATIENT AND STATE THE FOLLOWING: - DO NOT SOAK, WASH, STERILISE, OR RE-USE THIS PRODUCT. - DO NOT CRUSH OR STRETCH TUBE. - BEFORE CONNECTING TO PATIENT, CHECK FOR ADEQUATE GAS FLOW AND ENSURE THAT THE SYSTEM HAS WARMED UP.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT OPT544 OPTIFLOW NASAL CANNULAS (1 X LOT 131015, 1 X LOT 1405080302 AND 1 X LOT UNKNOWN) ARRIVED AT FISHER & PAYKEL HEALTHCARE IN (B)(6) AND ARE CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6), REPORTED TO OUR DISTRIBUTOR THAT THREE OPT544 OPTIFLOW NASAL CANNULA CAME APART CAUSING THE PATIENT'S OXYGEN SATURATION TO DECREASE. THE HOSPITAL FURTHER REPORTED THAT THE PATIENT WAS BEING AEROLIZED WITH VELETRI. PATIENT OXYGEN SATURATION RETURNED TO NORMAL UPON REPLACEMENT OF THE PRONGS.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6), REPORTED TO OUR DISTRIBUTOR THAT AN OPT544 OPTIFLOW NASAL CANNULA CAME APART, CAUSING THE PATIENT'S OXYGEN SATURATION TO DECREASE. THE HOSPITAL FURTHER REPORTED THAT THE PATIENT WAS BEING AEROLIZED WITH VELETRI. PATIENT OXYGEN SATURATION RETURNED TO NORMAL UPON REPLACEMENT OF THE CANNULA. TWO OTHER OCCASIONS WERE ALSO REPORTED WHERE THE TUBING HAD RIPPED, WITHOUT REPORTED PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715806 OPTIFLOW NASAL CANNULA CAT CAT FISHER & PAYKEL HEALTHCARE LTD OPT544

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention