BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEONATAL OXYGEN THERAPY NASAL CANNULA

    MDR report key: 1930926 · Received December 16, 2010

    Report

    Report Number
    9611451-2010-00759
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 23, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    CAT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE MANUFACTURE: 100710 - 07/10/2010; 100821 - 08/21/2010. BACKGROUND ON THE BC2435 NEONATAL OXYGEN THERAPY NASAL CANNULA: THE BC2435 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 MINIMISES 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 MINIMISED WHILE BEING AS PLIANT AS POSSIBLE TO ASSIST WITH POSITIONING. THE COMPLAINT BC2435 NEONATAL OXYGEN THERAPY NASAL CANNULAS WERE NOT RETURNED TO FPH FOR INVESTIGATION. OUR ANALYSIS IS ACCORDINGLY BASED ONLY ON THE EVENT DESCRIPTION PROVIDED BY THE HOSPITAL. FISHER & PAYKEL HEALTHCARE RECOGNISES 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. CHECK THE PATIENT'S SEPTAL INTEGRITY. FISHER & PAYKEL HEALTHCARE IS CONTINUALLY WORKING WITH CLINICIANS TO IMPROVE THE DELIVERY OF HIGH FLOW NASAL THERAPY TO NEONATAL PATIENTS AND TO FURTHER REDUCE THE RISKS ASSOCIATED WITH THIS THERAPY. FPH FIELD REPRESENTATIVES ARE WORKING WITH THE HOSPITAL TO REMIND THEM OF THE WARNINGS AND RECOMMENDATIONS OUTLINED IN THE LABELLING AND USER INSTRUCTIONS THAT ACCOMPANY THE BC2435 NEONATAL OXYGEN THERAPY NASAL CANNULA.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE MANUFACTURE: 100710 - 07/10/2010. 100821 - 08/21/2010. MANUFACTURER NARRATIVE: THE BC2435 NEONATAL OXYGEN THERAPY NASAL CANNULAS ARE EN ROUTE TO FISHER & PAYKEL HEALTHCARE 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 EVENTS AS REPORTED. WE WILL PROVIDE A FOLLOW UP REPORT ONCE WE RECEIVE FURTHER INFORMATION FROM THE HOSPITAL AND HAVE COMPLETED OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT BC2435 NEONATAL OXYGEN THERAPY NASAL CANNULAS WERE FOUND TO ALLEGEDLY HAVE "SHARP" EDGES. FURTHER INFORMATION RECEIVED FROM THE HOSPITAL REPORTED THAT THE CANNULAS WERE "TWISTING" OUT OF THE NOSE OF THE INFANTS, ALLEGEDLY CAUSING "BREAKDOWN OF THE NARES."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT TWO BC2435 NEONATAL OXYGEN THERAPY NASAL CANNULAS WERE FOUND TO HAVE SHARP EDGES. FURTHER INFORMATION RECEIVED FROM THE HOSPITAL REVEALED THAT THE CANNULAS WERE TWISTING OUT OF THE NOSES OF THE INFANTS, CAUSING "BREAKDOWN OF THE NARES".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEONATAL OXYGEN THERAPY NASAL CANNULA CAT CAT FISHER & PAYKEL HEALTHCARE LIMITED BC2435 100710, 100821

    Patients

    Seq Age Sex Outcome Treatment
    1