MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD AIRVO TUBE AND CHAMBER KIT WITH NEBULIZER ADAPTER; BTT

Model Number 900PT562

Device Problems Melted (1385); Material Too Soft/Flexible (4007)

Patient Problem Burn(s) (1757)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The f&p 900pt562 airvo tube and chamber kit with nebulizer adapter is not currently available for sale in the united states of america (usa) but it is similar to a product which is sold in the usa.The 510(k) for that product, the 900pt561 heated breathing tube and chamber kit, is k162553.The complaint 900pt562 airvo tube and chamber kit with nebulizer adapter is currently enroute to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative, that the heated breathing tube as part of a 900pt562 airvo tube and chamber kit with nebulizer adapter was found melted during use.It was further reported that the patient sustained a skin burn.No further patient consequences were reported.

Manufacturer Narrative

(b)(4).The f&p 900pt562 airvo tube and chamber kit with nebulizer adapter is not currently available for sale in the united states of america (usa) but it is similar to a product which is sold in the usa.The 510(k) for that product, the 900pt561 heated breathing tube and chamber kit, is k162553.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 900pt562 airvo heated breathing tube and chamber kit with nebulizer adapter was returned to fisher & paykel healthcare (f&p) for investigation where it was visually inspected and resistance tested.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 healthcare facility and f&p's knowledge of the product.Results: the resistance check on the heater wire of the returned device was within specification.The visual inspection revealed that the middle portion of the hbt had mostly softened and deformed (approximately 20cm), with only a few areas less than 1cm in size that indicated further melting.The healthcare facility has stated that the patient's skin was in contact with the hbt, resulting in a burn approximately 3-5cm in diameter sustained to their upper arm.It was reported that the patient did not require any medical intervention, indicating that the burn was not of a serious nature.The healthcare facility further reported that the circuit clip was not used to secure the hbt in place.Conclusion: we are unable to determine the cause of the reported event.However, damage to the hbt may be caused by factors such as incorrect set-up or covering it with a material or object for a prolonged period.Based on our investigation, it was confirmed that the patient's skin was in direct contact with the hbt for an unspecified period of time, which may have caused or contributed to the hbt damage.The 900pt562 user instructions 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 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." - "do not allow the breathing tube to remain in direct contact with skin for prolonged periods of time." all hbts as part of the 900pt562 airvo tube and chamber kits with nebulizer adapter 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 900pt562 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 any short circuit in the system.This functionality is checked by the control system when the airvo 2 is powering up before each use.- 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.

Event Description

A healthcare facility in sweden reported via a fisher & paykel healthcare (f&p) field representative, that the heated breathing tube as part of a 900pt562 airvo tube and chamber kit with nebulizer adapter was found melted during use.It was further reported that the patient sustained a skin burn, approximately 3-5cm in diameter, to their upper arm however no medical treatment was required, indicating the burn was not of a serious nature.No further patient consequences were reported.

• Brand Name: AIRVO TUBE AND CHAMBER KIT WITH NEBULIZER ADAPTER
• 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 ; 9494534002
• MDR Report Key: 14138552
• MDR Text Key: 294604836
• Report Number: 9611451-2022-00365
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012447517
• UDI-Public: (01)09420012447517(10)2101435612(11)201214
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/21/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 900PT562
• Device Catalogue Number: 900PT562
• Device Lot Number: 2101435612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2022
• Initial Date FDA Received: 04/18/2022
• Supplement Dates Manufacturer Received: 05/06/2022
• Supplement Dates FDA Received: 06/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2020
• 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 PT101 AIRVO 2 HUMIDIFIER; F&P PT101 AIRVO 2 HUMIDIFIER