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

Model Number 900PT561

Device Problems Melted (1385); Protective Measures Problem (3015)

Patient Problem Low Oxygen Saturation (2477)

Event Date 01/22/2022

Event Type  malfunction  

Event Description

A healthcare facility in (b)(6) reported that a 900pt561 airvo heated breathing tube used with a pt101 airvo2 humidifier was found melted due to a mucus build up.It was further reported that the nurse found the device alarming and the patient had desaturated.The subject airvo 2 humidifier and 900pt561 airvo heated breathing tube and chamber kit were replaced and the patient recovered.There were no further patient consequences.

Manufacturer Narrative

(b)(4).We are currently in the process of retrieving the complaint 900pt561 airvo heated breathing tube for evaluation.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in california reported that a 900pt561 airvo heated breathing tube used with a pt101 airvo2 humidifier was found melted due to a mucus build up.It was further reported that the nurse found the device alarming and the patient had desaturated.The subject airvo 2 humidifier and 900pt561 airvo heated breathing tube and chamber kit were replaced and the patient recovered.There were no further patient consequences.

Manufacturer Narrative

(b)(4).Method: the complaint heated breathing tube as part of the 900pt561 airvo heated breathing tube and chamber kit was returned to fisher & paykel healthcare (f&p) for investigation where it was visually inspected and resistance tested.Several attempts to request further information from healthcare facility were also made, however no response was provided by the healthcare facility.Our investigation is thus based on the evaluation of the complaint heated breathing tube and our knowledge of the product.Results: visual inspection of the heated breathing tube revealed that the heated breathing tube had melted, and a white fibrous material was observed to be embedded in the melted area.A brown substance was observed inside the tube at the interface end.The resistance check on the heater wire was within specification.Further information regarding the reported event was requested but was not provided conclusion: based on our knowledge of the product and our observation of the white fibrous material embedded in the melted area of the heated breathing tube, the reported damage was most likely caused by the tube being covered by a material and placed under a compressive load for a considerable length of time.All heated breathing tubes are 100% visually inspected using a camera system.The heated breathing tubes are also tested for resistance, continuity, polarity and pitch during production.Any product that fails the visual inspection and testing is disposed of.Additionally, the heated breathing tube includes an alert tag to warn the user that the heated breathing tube should not be covered in any way.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 heated breathing tube is within the limits specified by iso 8185 with regard to hot tube surface temperature not exceeding 44° celsius.There are many safety features incorporated into the airvo 2 system to prevent overheating and fire.These include: the heater wires in the heated breathing tube are completely insulated from the gas path.The pcb at the [patient] end of the heated breathing tube is over moulded with a thermoplastic polymer, ensuring it is excluded from the gas path.The airvo 2 contains a transient current detector, tcd.This tcd is tested on the production line.It is also checked by the control system when the airvo is powering up before each use.Temperature sensors in the airvo 2 will automatically cut power to the heater plate and heater wire if overheating in the heated breathing tube is detected.The airvo 2 is continuously checking power in the heated breathing tube and disables the heater wire if the measured power is too high.The airvo 2 humidifier user manual provides instructions for cleaning and maintenance including daily and weekly cleaning, followed by schedule for changing accessories, it also states: adding heat, above ambient levels, to any part of the breathing tube or interface, e.G.Covering with a blanket, or heating it in an incubator or overhead heater for a neonate, could result in serious injury use continuous oxygen monitoring on patients who would desaturate significantly in the event of disruption to their oxygen supply.Airvo 2 is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases the unit is not intended for life support.Appropriate patient monitoring must be used at all times.The 900pt562 airvo tube and chamber kit with nebulizer adapter 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 as this could result in serious injury.

• Brand Name: HEATED BREATHING TUBE AND CHAMBER KIT
• 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 ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534002
• MDR Report Key: 13589259
• MDR Text Key: 289075582
• Report Number: 9611451-2022-00173
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2022
• 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 PT101 AIRVO 2 HUMIDIFIER; F&P PT101 AIRVO 2 HUMIDIFIER