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

Model Number 900PT561

Device Problems Unraveled Material (1664); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

A healthcare facility in australia reported via a fisher & paykel healthcare (f&p) field representative that a section at the user end of the heated breathing tube (hbt) as part of the 900pt561 heated breathing tube and chamber kit had unraveled during use, with some minor melting present.This led to an alarm on the pt101 airvo 2 humidifier.There was no patient consequence.

Manufacturer Narrative

(b)(4).Fisher & paykel healthcare (f&p) has requested for the complaint device to be returned for evaluation.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 australia reported via a fisher & paykel healthcare (f&p) field representative that a section at the user end of the heated breathing tube (hbt) as part of the 900pt561 heated breathing tube and chamber kit had unraveled during use, with some alleged minor melting present.This led to an alarm on the pt101 airvo 2 humidifier.The subject device was immediately replaced with a new hbt, and returned to normal operation.There was no patient consequence.

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.The subject hbt as part of the heated breathing tube and chamber kit was received at fisher & paykel healthcare (f&p) in new zealand for investigation, where it was visually inspected.Investigation of the subject device confirmed that there was no evidence of melting present on the hbt.This event was initially reported out of abundance of caution as a melted hbt, however no melted damage was confirmed from our investigation of the subject device.There were also no patient consequences reported.A historical search was conducted of post market surveillance data to determine whether the reported failure mode has caused or contributed to serious injury or death, and no such instance was identified.F&p does not consider this event to meet the fda reportability criteria.The 900pt561 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 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.

• 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: 17600574
• MDR Text Key: 321746757
• Report Number: 9611451-2023-00727
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K162553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/24/2023

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: 900PT561
• Device Catalogue Number: 900PT561
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 07/24/2023
• Initial Date FDA Received: 08/22/2023
• Supplement Dates Manufacturer Received: 08/29/2023
• Supplement Dates FDA Received: 09/28/2023
• 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: Reuse
• Patient Sequence Number: 1
• Treatment: F&P OPT316 OPTIFLOW JUNIOR NASAL CANNULA; F&P OPT316 OPTIFLOW JUNIOR NASAL CANNULA; F&P PT101 AIRVO 2 HUMIDIFIER; F&P PT101 AIRVO 2 HUMIDIFIER