BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEONATAL OXYGEN THERAPY NASAL CANNULA

    MDR report key: 1888629 · Received November 2, 2010

    Report

    Report Number
    9611451-2010-00656
    Event Type
    Injury
    Date Received
    November 2, 2010
    Report Date
    October 6, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    CAT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).LOT # AND DEVICE MANUFACTUREQUANTITY LOT # DEVICE MANUFACTURE11 090919 09/19/20095 091010 10/10/2009 17 091121 11/21/2009(A) BACKGROUND INFORMATION ON BC2425 NEONATAL OXYGEN THERAPY NASAL CANNULATHE BC2425-20 OXYGEN PRONGS ARE WIDELY USED FOR THE DELIVERY OF HIGH FLOW THERAPY TO NEONATAL PATIENTS. THIS THERAPY IS GAINING POPULARITY AS AN ALTERNATIVE TO MORE INVASIVE THERAPIES. OBVIOUSLY THE SIZE AND DELICATE CONDITION OF NEONATAL PATIENTS MAKES THE PROVISION OF THIS THERAPY CHALLENGING. IN PARTICULAR THE CLINICIAN MUST POSITION THE PRONGS IN THE NARES IN A WAY THAT ENSURES DELIVERY OF THE THERAPY BUT MINIMIZES DAMAGE TO THE SEPTUM AND OTHER DELICATE AREAS OF THE NOSE. THIS REQUIRES THE TUBING LEADING TO THE PRONGS TO BE ANCHORED IN SOME WAY, USUALLY USING SPECIALLY DESIGNED TAPES WHICH ADHERE THE TUBING TO THE FACE. EVEN WHEN BEST PRACTICE IS EMPLOYED, SKIN DAMAGE IS A COMMON SIDE EFFECT OF SUCH TREATMENT. THERE IS ALSO A LOW RISK OF THE GAS FLOW BEING OCCLUDED IF THE PRONGS ARE NOT POSITIONED CORRECTLY. FURTHERMORE, THERE ARE INHERENT TRADE-OFFS IN THE DESIGN OF THE TUBING AND PRONGS. IN PARTICULAR, THE TUBING MUST BE STIFF ENOUGH SO THAT THE RISK OF OCCLUSION THROUGH KINKING IS MINIMIZED WHILE BEING AS PLIANT AS POSSIBLE TO ASSIST WITH POSITIONING. (B) MANUFACTURER NARRATIVEMETHOD: A QUANTITY OF 33 UNUSED BC2425 NASAL CANNULAS THAT WERE RETRIEVED FROM THE HOSPITAL WERE RETURNED TO FPH (B)(4) FOR INVESTIGATION. THE COMPLAINT DEVICES WERE VISUALLY INSPECTED FOR THE REPORTED FAULT. RESULTS: OUR INVESTIGATION REVEALED THAT THERE WAS NO DAMAGE TO THE NASAL CANNULAS OR PRONGS. THERE IS NO DEVIATION OF THE CANNULA DIMENSIONS FROM THE DESIGN DRAWINGS. CONCLUSION: THE REPORTED FAULT WAS MOST LIKELY DUE TO IMPROPER FITTING, SIZING OR POSITIONING OF THE CANNULA TUBING ON THE PATIENT'S FACE. FISHER & PAYKEL HEALTHCARE RECOGNIZES THAT CORRECT CANNULA SIZE SELECTION, CORRECT PRONG PLACEMENT AND FIT, AND CAREFUL PATIENT MONITORING ARE VITAL IN ENSURING THE PATIENT RECEIVES THE BENEFITS OF NASAL THERAPY WHILE MINIMIZING THE POTENTIAL FOR OCCLUSION, SKIN IRRITATION OR SEPTAL INJURY.THE DEVICE USER INSTRUCTIONS STATE THE FOLLOWING:- SELECT THE CORRECT SIZE NASAL CANNULA, THE NASAL PRONG OUTER DIAMETER SHOULD BE APPROXIMATELY HALF THE DIAMETER OF THE INFANT'S NARES.- PLACE THE NASAL CANNULA IN THE NARES ENSURING THAT THERE IS AT LEAST A 2 MM (0.08 INCHES) GAP FROM THE SEPTUM.- ENSURE THAT THE NASAL PRONGS ARE POSITIONED AT LEAST 2MM (0.08 INCHES) FROM THE SEPTUM TO AVOID PRESSURE NECROSIS. RE-ADJUST AS NECESSARY.- PLACE HAND CLOSE TO THE NASAL PRONGS TO ENSURE THAT THERE IS AIRFLOW EXITING THE PRONGS.FISHER & PAYKEL HEALTHCARE IS CONTINUALLY WORKING WITH CLINICIANS AND OUR SUPPLIER TO IMPROVE THE DELIVERY OF HIGH FLOW NASAL THERAPY TO NEONATAL PATIENTS AND TO FURTHER REDUCE THE RISKS ASSOCIATED WITH THIS THERAPY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT BC2425 NASAL CANNULA USED ON THE BABY HAD BEEN DESTROYED AT THE HOSPITAL. A QUANTITY OF 33 UNUSED BC2425 NASAL CANNULAS THAT WERE RETRIEVED FROM THE HOSPITAL ARE EN ROUTE TO FPH (B)(4) FOR INVESTIGATION. WE ARE CURRENTLY IN THE PROCESS OF OBTAINING FURTHER INFORMATION FROM THE HOSPITAL IN ORDER TO ASSIST US WITH THE ANALYSIS AND IDENTIFICATION OF A POSSIBLE ROOT CAUSE OF THE EVENT AS REPORTED. WE WILL PROVIDE A FOLLOW UP REPORT ONCE WE RECEIVE FURTHER INFORMATION FROM THE HOSPITAL AND HAVE COMPLETED OUR INVESTIGATION. THE LOT NUMBERS AND MANUFACTURING DATES OF THE 33 UNUSED BC2425 NASAL CANNULAS THAT WERE RETRIEVED FROM THE HOSPITAL ARE AS FOLLOW: 090919 - 09/19/2009. 091010 - 10/10/2009. 091121 - 11/21/2009.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT A BC2425 NEONATAL OXYGEN THERAPY NASAL CANNULA ALLEGEDLY CAUSED TISSUE BREAKDOWN IN THE BABY'S NOSE. THIS WAS NOTICED DURING USE ON A PATIENT. THE COMPLAINT BC2425 NASAL CANNULA HAS BEEN DISCARDED BY THE HOSPITAL. IT WAS FURTHER REPORTED THAT THEY COULD NOT IDENTIFY THE LOT NUMBER OF THE BC2425 USED ON THE BABY.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT A BC2425 NEONATAL OXYGEN THERAPY NASAL CANNULA CAUSED TISSUE BREAKDOWN IN THE BABY'S NOSE. THIS WAS NOTICED DURING USE ON A PATIENT. THE COMPLAINT BC2425 NASAL CANNULA HAS BEEN DISCARDED BY THE HOSPITAL. IT WAS FURTHER REPORTED THAT THEY COULD NOT IDENTIFY THE LOT NUMBER OF THE BC2425 USED ON THE BABY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEONATAL OXYGEN THERAPY NASAL CANNULA CAT CAT FISHER & PAYKEL HEALTHCARE LIMITED BC2425

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention