MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD HEATED BREATHING TUBE AND CHAMBER KIT

Model Number 900PT561

Device Problem Melted (1385)

Patient Problem Low Oxygen Saturation (2477)

Event Date 01/26/2024

Event Type  malfunction  

Event Description

A healthcare facility in the united kingdom reported via a fisher and paykel healthcare (f&p) field representative that a small section of tubing at the patient end of the heated breathing tube (hbt) as part of the 900pt561 heated breathing tube and chamber kit was found melted during use.It was also reported by the healthcare facility that the patient was inside an infant warmer and that the hbt was being used with an ojr412 small optiflow junior 2 nasal cannula and a pt101 airvo 2 humidifier which was set to adult mode.The healthcare facility further reported that at the time of event the patient desaturated to 80% spo2.It was reported that the patient was given oxygen via a non-rebreather mask while the device setup was replaced.It was reported that the patient saturation improved to 100% spo2 with no further consequences.

Manufacturer Narrative

(b)(4).Fisher & paykel healthcare is in the process of completing our investigation.We will provide a follow up report upon completion of our investigation.Product background: the heated breathing tube (hbt) is a component designed for use with the airvo 2 humidifier (airvo 2), for the delivery of humidified respiratory gases to patients, including those who are receiving nasal high flow (nhf) therapy.Nhf therapy is intended for use with spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.The airvo 2 device should not be used for life support purposes, and appropriate patient monitoring must be used at all times.The hbt as part of the airvo 2 system contains a heater wire encapsulated in plastic which ensures optimal temperature and humidification levels are delivered to the patient interface while minimizing the amount of condensate in the tube.

Event Description

A healthcare facility in the united kingdom reported via a fisher and paykel healthcare (f&p) field representative that a small section of tubing at the patient end of the heated breathing tube (hbt) as part of the 900pt561 heated breathing tube and chamber kit was found melted during use.It was also reported by the healthcare facility that the patient was inside an infant warmer and that the hbt was being used with a red optiflow junior nasal cannula and a pt101 airvo 2 humidifier which was set to adult mode at 10l/min, 37°c.The healthcare facility further reported that at the time of event the patient desaturated to 80% spo2.It was reported that the patient was given oxygen via a non-rebreather mask while the device setup was replaced.It was reported that the patient saturation improved to 100% spo2 with no further consequences.

Manufacturer Narrative

(b)(4).Product background: the heated breathing tube (hbt) is a component designed for use with the airvo 2 humidifier (airvo 2), for the delivery of humidified respiratory gases to patients, including those who are receiving nasal high flow (nhf) therapy.Nhf therapy is intended for use with spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.The airvo 2 device should not be used for life support purposes, and appropriate patient monitoring must be used at all times.The hbt as part of the airvo 2 system contains a heater wire encapsulated in plastic which ensures optimal temperature and humidification levels are delivered to the patient interface while minimizing the amount of condensate in the tube.Method: the subject hbt as part of the 900pt561 heated breathing tube and chamber kit was received at fisher & paykel healthcare (f&p) in new zealand for investigation, where it was resistance tested and visually inspected.The healthcare facility also provided additional information relating to the reported event upon request.Our investigation is thus based on the evaluation of the subject hbt, the information provided by the customer and our knowledge of the product.Results: the resistance check on the heater wire was within specification.The visual inspection revealed that a small section of the hbt was melted and delaminated near the patient end connector.The healthcare facility reported that they had been using a red optiflow junior nasal cannula and a airvo 2 which was set to adult mode.The device model of the nasal cannula was not specified, the red colour notes that the interface would be the small size of an optiflow junior nasal cannula, either a opt312 or ojr412.The healthcare facility also reported that the patient was inside the infant warmer at the time of event.Information on whether the hbt had been placed within the infant warmer was requested, however the healthcare facility did not provide a response despite several requests by f&p.It was further reported by the healthcare facility that the patient desaturated to 80% spo2 at the time of event and that the patient was given a non-rebreather mask while the subject device was replaced.The patient saturation recovered and there were no further consequences reported.Conclusion: we are unable to determine the exact cause of the reported event as there were several factors which could have contributed to the reported damage.- it was reported that the patent was in an infant warmer at the time of event.The 900pt561 user instructions state "do not add heat to any part of the breathing tube e.G., covering with a blanket, or heating it in an incubator or overhead heater for a neonate, as this could result in serious injury." - the small nasal interface used, either the opt312 or ojr412, is not intended for use with the airvo 2.The airvo 2 user instructions list the optiflow junior and optiflow junior 2 interfaces that can be used with the airvo 2, stating "do not use any patient interfaces not listed here." - additionally, the airvo 2 used was in adult mode with settings of 10l/min at 37°c.In junior mode the maximum temperature is 34°c.The maximum flow rate for the small optiflow junior nasal cannula is 8l/min.The airvo 2 user instructions state "if the patient will be using an optiflow junior nasal interface (opt316/ojr416/opt318/ojr418), you must activate junior mode." the 900pt561 user instructions also show in pictorial format the correct placement of the device and includes the following information: - "connect breathing tube clip to patient clothing or bedding." - "never operate the unit if the breathing tube has been damaged with holes, tears or kinks" - "do not block the flow of air through the unit and breathing tube." - "do not allow the breathing tube to remain in direct contact with skin for prolonged periods of time." all hbts as part of the 900pt561 heated breathing tube and chamber kit are visually inspected and undergo functional tests, including soak and temperature, and heater wire resistance.The heated breathing tubes are 100% visually inspected using a camera system.The hbts are also tested for resistance, continuity, polarity and pitch during production.Additionally, a functional test is conducted under load.The hbt would have met the required specifications at the time of production.The airvo 2 system is designed to comply with the electrical safety standard iec 60601-1: 2005+a1:2012.The case is composed of a flame retardant material.The surface temperature of the hbt, when used in accordance with user instructions, is designed to be within the limits specified by iso 8185 with regard to hot tube surface temperature not exceeding 44° celsius.It is an inherent risk of hbts, that additional heat (above ambient levels) added to any part of the tube via an external source or being covered with material, may lead to the tubing becoming damaged.To address this inherent risk and as is required under iso 80601, the user instructions for the 900pt561 contains the warning "do not add heat to any part of the breathing tube e.G.Covering with a blanket, or heating it in an incubator or overhead heater for a neonate, as this could result in serious injury." additional "do not cover" tags are also attached to all hbts to alert the user that the hbt should not be covered.There are many safety features incorporated into the airvo 2 system to prevent overheating and fire.These include: - the heater wires in the hbt are completely insulated from the gas path.- the pcb at the [patient] end of the hbt is over moulded with the thermoplastic polymer polypropylene, ensuring it is excluded from the gas path.- the airvo 2 device contains technology which detects short circuits and transient current events in the hbt.When detected, the airvo removes power to the hbt.The airvo 2 performs this detection at any time it is turned on and connected to the hbt.This functionality is checked by the control system each time the airvo is powered up, or when a new hbt is connected.- an 'over-temperature' sensor will automatically cut power to the motor, heater plate and heater wire if it detects any overheating at the chamber or the patient end of the hbt.- the airvo 2 device is continuously checks power in the hbt and disables the heater wire if the measured power is too high.

• Brand Name: HEATED BREATHING TUBE AND CHAMBER KIT
• Type of Device: HEATED BREATHING TUBE
• 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: omid taheri ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 8007923912
• MDR Report Key: 18764475
• MDR Text Key: 336961467
• Report Number: 9611451-2024-00119
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K162553
• 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: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 900PT561
• Device Catalogue Number: 900PT561
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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 OJR412 OPTIFLOW JUNIOR 2 NASAL CANNULA.; F&P PT101 AIRVO 2 HUMIDIFIER.; F&P PT101 AIRVO 2 HUMIDIFIER.
• Patient Age: 3 MO