MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD HEATED BREATHING TUBE AND CHAMBER KIT WITH NEBULIZER ADAPTER; AUTOFILL CHAMBER

Model Number 900PT562

Device Problem Fluid/Blood Leak (1250)

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

Event Date 05/30/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Fisher & paykel healthcare (f&p) is currently in the process of completing our investigation.We will provide a follow up report upon completion of our investigation.Product background: the autofill chamber as part of the 900pt562 heated breathing tube and chamber kit with nebulizer adapter is a component designed for use with the airvo 2 humidification series to provide nasal high flow (nhf) therapy.Air and oxygen are blown from the airvo 2 into the humidification chamber within which water is heated by a heater plate.The gases become humidified in the chamber and then pass into a heated breathing tube, then to the patient interface.Nhf therapy is intended for use with spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases nhf therapy should not be used for life support purposes, and appropriate patient monitoring must be used at all times.

Event Description

A distributor reported on behalf of a healthcare facility in thailand via a fisher and paykel healthcare (f&p) field representative that the autofill chamber as part of the 900pt562 heated breathing tube and chamber kit with nebulizer adapter was found leaking water during use.There were no reported patient consequences.

Manufacturer Narrative

(b)(4).Product background: the autofill chamber as part of 900pt562 heated breathing tube and chamber kit with nebulizer adapter is a component designed for use with the airvo 2 humidification series to provide nasal high flow (nhf) therapy.Air and oxygen are blown from the airvo 2 into the humidification chamber within which water is heated by a heater plate.The gases become humidified in the chamber and then pass into a heated breathing tube, then to the patient interface.Nhf therapy is intended for use with spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases nhf therapy should not be used for life support purposes, and appropriate patient monitoring must be used at all times.Method: the complaint autofill chamber was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the information provided by the healthcare facility, previous investigations of similar complaints, and our knowledge of the product.Results: the healthcare facility reported that the autofill chamber was found leaking during use.However, upon investigation, the healthcare facility reported that the water feed set tube on the autofill chamber was found leaking.Conclusion: without the return of the complaint device, we are unable to confirm the cause of the reported event.Based on our knowledge of the product, it is possible that the water feedset tubing was subjected to an external force.Every autofill chamber is pressure tested following the manufacturing process to check for any leaks present in the chamber dome and water feedset.In addition, destructive pull testing is performed hourly to verify the strength of the water feedset tubing.Any chamber which fails either of these tests is rejected.The subject chamber would have met the required specification at the time of production.The user instructions that accompany the 900pt56 heated breathing tube and chamber kit with nebulizer adapter show in pictorial format the correct placement and fitting of the autofill chamber and water feed set tube.The user instructions also state the following: "do not use the autofill chamber if it has been dropped or been allowed to run dry as this could lead to the chamber over-filling." do not use the autofill chamber if the water level rises above the maximum water level line as this may lead to water entering the patient's airway." "for single patient use only.Reuse may result in transmission of infectious substances.Attempting to reprocess will result in degradation of materials and render the product defective." "avoid contact with chemicals, cleaning agents, or hand sanitizers.".

Event Description

A distributor reported on behalf of a healthcare facility in thailand via a fisher and paykel healthcare (f&p) field representative that the autofill chamber as part of the 900pt562 heated breathing tube and chamber kit with nebulizer adapter was found leaking water during use.Further information later provided by the healthcare facility confirmed that the autofill chamber was found leaking water from the water feed set tube during use and there was no leak from the chamber base or dome.There were no reported patient consequences.

• Brand Name: HEATED BREATHING TUBE AND CHAMBER KIT WITH NEBULIZER ADAPTER
• Type of Device: AUTOFILL CHAMBER
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 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: 17358154
• MDR Text Key: 319757036
• Report Number: 9611451-2023-00666
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012447517
• UDI-Public: (01)09420012447517(10)2102549932(11)230315
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K131895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2023
• 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: 2102549932
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2023
• 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: PT101 AIRVO 2 HUMIDIFIER