MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD OPTIFLOW FILTERED NASAL INTERFACE; BTT

Model Number AA001M

Device Problems Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)

Patient Problems Burn(s) (1757); Superficial (First Degree) Burn (2685)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Fisher and paykel healthcare (f&p) are currently in the process of obtaining further information regarding the reported event.We have also requested the return of the subject aa001 optiflow filtered nasal interface and aa451 optiflow oxygen kit to f&p new zealand for investigation.We will provide a follow up report upon completion of our investigation.Product background: the aa001 optiflow filtered nasal interface is a nasal interface designed to be used with a respiratory humidifier and a breathing kit such as the aa451 optiflow oxygen kit.The aa001 optiflow filtered nasal interface consists of a headstrap, attached to the interface, and a filter providing bacterial and viral filtration.The headstrap fits around the back of the patient's head to hold the interface in place on the patient's face.The interface consists of prongs which are inserted into the patient's nares.The aa451 optiflow oxygen kit consists of components including tubes, required for the delivery of gases from the respiratory humidifier to the nasal interface.The aa001 optiflow filtered nasal interface is used to deliver respiratory gases to adult patients in hospitals and medical facilities.It is indicated for the delivery of nasal high flow in spontaneously breathing patients by appropriately qualified healthcare professionals and for apneic patients in operating and procedure rooms under the direction of an appropriately qualified anesthetist, anesthesiologist, or medical professional.This product is an open oxygen delivery system.Open oxygen delivery can increase the risk of a surgical fire occurring, causing serious injury or death.The user instructions supplied with the aa001 optiflow filtered nasal interface warn of fire danger and specifically advise to "ensure gas flow from the product is not in or near the surgical field and the surgical site is free of all potential fuel sources, including alcohol skin preparation, gauze, sponges and drapes before potential ignition sources, such as electrosurgery, electrocautery or laser devices are used." additionally, the user instructions supplied with aa451 optiflow oxygen kit advise "do not use product near any ignition sources, including electrosurgery, electrocautery or laser surgery instruments.Exposure to oxygen increases the risk of fire that may cause serious injury or death.".

Event Description

A healthcare facility in poole reported via a fisher & paykel healthcare (f&p) field representative that during a standard laser procedure of a subglottic stenosis, the surgeon tested the laser on a wooden stick to the side of the patient.It was reported that the wooden stick burned as expected and ignited the gamgee that was in use on the patient's face and neck.F&p's aa001 optiflow filtered nasal interface and aa451 optiflow oxygen kit were part of the set-up used in the procedure.It was reported that the surgeons reacted instantly to the event by dousing the fire and stopping the high flow oxygen and the jet ventilator which was also in use.The f&p field representative reported that the customer initially reported on (b)(6) 2023 that the patient was found to have mainly superficial burns to the shoulder, face and hair line, mostly on the left side of the patient.Further information provided by the customer on (b)(6) 2023 indicated that the patient also suffered some isolated deep burns.It was reported that the burns were cooled and dressed and that the reported incident resulted in an additional 2 days stay in hospital for the patient.On (b)(6) 2023, the customer reported that the patient should make a good recovery with no permanent damage.The customer also stated that they routinely tested the laser with the patient in the room.However, the customer indicated that this will no longer be the practice going forward.

Event Description

A healthcare facility in poole reported via a fisher & paykel healthcare (f&p) field representative that during a standard laser procedure of a subglottic stenosis, the surgeon tested the laser on a wooden stick to the side of the patient.It was reported that the wooden stick burned as expected and ignited the gamgee that was in use on the patient's face and neck.F&p's aa001 optiflow filtered nasal interface and aa451 optiflow oxygen kit were part of the set-up used in the procedure.It was reported that the surgeons reacted instantly to the event by dousing the fire and stopping the high flow oxygen and the jet ventilator which was also in use.The f&p field representative reported that the customer initially reported on (b)(6) 2023 that the patient was found to have mainly superficial burns to the shoulder, face and hair line, mostly on the left side of the patient.Further information provided by the customer on the (b)(6) 2023 indicated that the patient also suffered some isolated deep burns.It was reported that the burns were cooled and dressed and that the reported incident resulted in an additional 2 days stay in hospital for the patient.On the 15th of february 2023, the customer reported that the patient should make a good recovery with no permanent damage.No further patient consequences were reported.The customer also stated that they routinely tested the laser with the patient in the room.However, the customer indicated that this will no longer be the practice going forward.

Manufacturer Narrative

(b)(4).The aa001m optiflow filtered nasal interface is not sold in the united states of america (usa) but is considered similar to products sold in the usa.The 510(k) for these products is k201723.Method: the complaint aa001 optiflow filtered nasal interface was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on information provided by the customer and our knowledge of the product.F&p have made multiple attempts to get the device returned for evaluation and obtain further information with regards to the batch number of the products however, no further information was provided by the customer.Results: the customer reported that during a laser procedure, the surgeon tested the laser on a wooden stick to the side of the patient.The wooden stick burned and ignited the gamgee that was in use on the patient's face and neck.The customer reported that the patient was found to have mainly superficial burns to the shoulder, face and hair line, mostly on the left side, and some isolated deep burns.The customer reported that the patient should make good recovery with no permanent damage.The customer stated that they routinely tested the laser with the patient in the room but will discontinue this practice.The customer advised fisher & paykel healthcare of a possible theory of a disconnection between the aa451 optiflow oxygen kit circuit and the filter supplied with the aa001 optiflow filtered nasal interface but could not confirm whether or not any disconnection occurred.The user instructions supplied with the aa001 optiflow filtered nasal interface state the following: fire danger this product is an open oxygen delivery system.Open oxygen delivery can increase the risk of a surgical fire occurring, causing serious injury or death.Extreme care must be taken.The following is advised.Warning: do not use this product where ignition sources and fuel are present.Use with ignition sources and fuel present completes the fire triangle, increasing the risk of fire.The following steps should be taken to reduce the risk of a surgical fire occurring: ensure gas flow from the product is not in or near the surgical field and the surgical site is free of a potential fuel source, including alcohol skin preparation, gauze, sponges and drapes before potential ignition sources, such as electrosurgery, electrocautery or laser devices are used.Ensure the room is adequately ventilated as oxygen may accumulate over time.Follow the instructions for use of all surgical devices, including electrosurgery, electrocautery and laser devices, regarding oxygen delivery.The user instructions supplied with the aa451 optiflow oxygen kit state the following: warnings.Do not use product near any ignition source, including electrosurgery, electrocautery, or laser surgery instruments.Exposure to oxygen increases the risk of fire that may cause serious injury or death.Failure to comply with the following warnings may impair performance of the device or compromise safety (including potentially cause serious harm): check all connections are tight before use.Conclusion: without the complaint device, fisher & paykel healthcare is unable to confirm if there were any faults that may have contributed to the event.The use of the aa001 optiflow filtered nasal interface and aa451 optiflow oxygen kit near any ignition sources (such as laser) is warned against in the user instructions supplied with the products.Inspections are performed on every batch of the aa451 optiflow oxygen kit circuit connector and aa001 optiflow filtered nasal interface filter connector to ensure that the components are manufactured within specifications.There have been no complaints of disconnection between the aa451 optiflow oxygen kit circuit and the aa001 optiflow filtered nasal interface filter in the last five years.

• Brand Name: OPTIFLOW FILTERED NASAL INTERFACE
• Type of Device: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: faranak gomarooni ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534000
• MDR Report Key: 16464676
• MDR Text Key: 310491335
• Report Number: 9611451-2023-00144
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AA001M
• Device Catalogue Number: AA001M
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: F&P 950 RESPIRATORY HUMIDIFER; F&P 950 RESPIRATORY HUMIDIFER; F&P AA451 OPTIFLOW OXYGEN KIT; F&P AA451 OPTIFLOW OXYGEN KIT
• Patient Outcome(s): Hospitalization; Other