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

Model Number AA001M

Device Problem Fire (1245)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The optiflow thrive system is indicated for use in the hospital during peri-intubation, peri-extubation, procedural sedation, and post-anaesthesia care.It is intended to be used in conjunction with the mr810 humidifier to deliver humidified oxygen.The use of diathermy devices presents a significant risk of fire in the presence of a fuel source.The use of supplementary oxygen can increase this risk.This risk is generally well understood by operating room staff.Our user instructions contain the following warning: "do not use system near any ignition source, including electrosurgery, electrocautery, or laser surgery instruments.Exposure to oxygen increases the risk of fire that may result in patient injury or death." in the reported event, it was stated that a surgical fire occurred during an awake tracheostomy in which optiflow thrive nasal interface was being used to provide supplemental oxygen to a patient having a lesion removed from the vocal cords.Electrical monopolar diathermy used during the procedure ignited from top of the incision "burning caudally".It was also reported that "before the operation began, the surgical plan and risks, including fire, were discussed with all theatre team".The use of the optiflow thrive nasal interface was ceased upon commencement of the fire.It was also reported that the optiflow high-flow nasal oxygen was later restarted and surgery was completed "uneventfully".The report also summarizes "when using high flows of concentrated oxygen, practitioners should aim to minimize all of these factors and be alert for the risk of fire at every stage of the operation".

Event Description

A fisher & paykel healthcare (f&p) staff member became aware of an event involving an occurrence of a surgical fire while the aa001 optiflow thrive nasal interface was in use.This was published in an anaesthesia case report titled "airway fire during awake tracheostomy using high-flow nasal oxygen" written by t.R.P.Adams and a.Ricciardelli.It was reported in the article that a patient was admitted to the emergency department where he was diagnosed with "crusted lesions on the posterior two-thirds of the vocal cords and significant supraglottic erythema and oedema" and the patient was consented for an awake tracheostomy under local anesthesia.It was also reported that the patient was transported to the operating table and positioned head-up with standard monitoring applied.It was further reported that the patient was on optiflow high-flow nasal oxygen with a set flow rate of 30 lpm and 1.0 fio2, lightly sedated with a total of 2 mg midazolam and 100 lg fentanyl.After the patient was appropriately sedated, oxygen flow rates were increased to 60 lpm.It was reported that electrical monopolar diathermy was used to control bleeding vessels during the surgical procedure.During diathermy, approximately 2 mm below the skin "a jet of flame ignited from top of the incision, burning caudally".It was further reported that the surgeon ceased diathermy and "simultaneously extinguished the flame with his hand" and the anaesthetist turned the oxygen off.The patient was inspected for accidental damage or burns and it was reported that none were found.No further patient consequences were reported.As per us fda safety communication issued may 29, 2018: "recommendations to reduce surgical fires and related patient injury" f&p has elected to voluntarily report this event.

• Brand Name: OPTIFLOW THRIVE NASAL INTERFACE
• Type of Device: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 10382989
• MDR Text Key: 202156949
• Report Number: 9611451-2020-00679
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K033008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial
• Report Date: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AA001M
• Device Catalogue Number: AA001M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/10/2020
• Initial Date FDA Received: 08/08/2020
• 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
• Patient Age: 49 YR
• Patient Weight: 133