MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD OPTIFLOW FILTERED NASAL INTERFACE WITH CO2 SAMPLING; BTT

Model Number AA031M

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Burn(s) (1757); Insufficient Information (4580)

Event Date 02/14/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).The aa031m optiflow filtered nasal interface with co2 sampling 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.Based on the currently available information, there was no malfunction with the aa031 optiflow filtered nasal interface with co2 sampling and aa451 optiflow oxygen kit.This incident was reported to f&p as the products were in use at the time.As part of f&p's normal process, we are in the process of obtaining further information regarding the reported event.We have also requested the return of the subject aa031 optiflow filtered nasal interface with co2 sampling and aa451 optiflow oxygen kit to f&p new zealand for investigation.F&p will provide a follow up report upon completion of investigation.Product background: the aa031 optiflow filtered nasal interface with co2 sampling is a nasal interface designed to be used with a respiratory humidifier and a breathing kit such as the aa451 optiflow oxygen kit.The aa031 optiflow filtered nasal interface with co2 sampling 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 and a carbon dioxide sampling wand that is attached alongside the interface.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 aa031 optiflow filtered nasal interface with co2 sampling 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 and for apneic patients in operating and procedure rooms under the direction of an appropriately qualified healthcare professionals.The user instructions supplied with the aa031 optiflow filtered nasal interface with co2 sampling state the following under the fire danger section: ·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.· contraindication: "do not use this product with electrosurgery or electrocautery devices on the head or neck" and · warning "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 australia reported via a fisher & paykel healthcare (f&p) field representative that during a procedure to remove a skin lesion from a patient's head using diathermy, the patient received a serious burn to their head and neck.The f&p aa031 optiflow filtered nasal interface with co2 sampling and aa451 optiflow oxygen kit were part of the set up used in the procedure.There was no reported malfunction of the aa031 optiflow filtered nasal interface with co2 sampling and aa451 optiflow oxygen kit and this incident was reported to us as the aa031 optiflow filtered nasal interface with co2 sampling and aa451 optiflow oxygen kit were in use at the time.The f&p field representative reported that a patient was intubated and transferred to another hospital's intensive care unit.F&p has requested further information on the patient's current status and the reported incident.

Manufacturer Narrative

(b)(4).The aa031m optiflow filtered nasal interface with co2 sampling 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 aa031 optiflow filtered nasal interface with co2 sampling and aa451 optiflow oxygen kit were not returned to fisher & paykel healthcare (f&p) for evaluation.F&p have made multiple attempts to get the device returned to new zealand and to obtain further information with regards to the reported event including the patient status, however no further information was provided by the customer.Our investigation is based on the initial information provided by the customer and our knowledge of the product.Results: the customer reported that during a procedure to remove a skin lesion from a patient's head using diathermy, the patient received a serious burn to their head and neck.The f&p aa031 optiflow filtered nasal interface with co2 sampling and aa451 optiflow oxygen kit were part of the set up used in the procedure.There was no reported malfunction of the aa031 optiflow filtered nasal interface and aa451 optiflow oxygen kit.The aa031 optiflow filtered nasal interface with co2 sampling is a nasal interface designed to be used with a respiratory humidifier and a breathing kit such as the aa451 optiflow oxygen kit.The aa031 optiflow filtered nasal interface with co2 sampling is used for the delivery of nasal high flow of respiratory gases (oxygen and/or air) to adult patients in hospitals and medical facilities.Based on the information provided by the customer, all three aspects of the fire triangle (fuel, oxidizer and ignition) were present in this incident.The user instructions supplied with the aa031 optiflow filtered nasal interface with co2 sampling state the following: the following are contraindicated for this product.Failure to comply can lead to serious injury or death.Do not use this product with electrosurgery or electrocautery devices on the head or neck.Refer to the fire danger information.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.Contraindication: do not use this product with electrosurgery or electrocautery devices on the head or neck.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 surgical fire occurring.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.Follow the instructions for use of all surgical devices, including electrosurgery, electrocautery and laser devices, regarding oxygen delivery.Additionally, the warnings in the user instructions supplied with aa451 optiflow oxygen kit state: -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.Conclusion: the customer did not report any fault of the aa031 optiflow filtered nasal interface and aa451 optiflow oxygen kit.The use of diathermy, which is a form of electrocautery, with the aa031m filtered nasal interface with co2 sampling is contraindicated for the head and neck in the user instructions supplied with the product.

Event Description

A healthcare facility in australia reported via a fisher & paykel healthcare (f&p) field representative that during a procedure to remove a skin lesion from a patient's head using diathermy, the patient received a serious burn to their head and neck.The f&p aa031 optiflow filtered nasal interface with co2 sampling and aa451 optiflow oxygen kit were part of the set up used in the procedure.There was no reported malfunction of the aa031 optiflow filtered nasal interface with co2 sampling and aa451 optiflow oxygen kit and this incident was reported to us as the aa031 optiflow filtered nasal interface with co2 sampling and aa451 optiflow oxygen kit were in use at the time.The f&p field representative reported that a patient was intubated and transferred to another hospital's intensive care unit.No further patient consequences were reported.

• Brand Name: OPTIFLOW FILTERED NASAL INTERFACE WITH CO2 SAMPLING
• 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: 16561074
• MDR Text Key: 311474733
• Report Number: 9611451-2023-00206
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AA031M
• Device Catalogue Number: AA031M
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2023
• 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): Other; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Male