MAUDE Adverse Event Report: HEATED BREATHING TUBE AND CHAMBER KIT; AUTOFILL CHAMBER

Model Number 900PT561

Device Problem Fluid/Blood Leak (1250)

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

Event Date 01/16/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product background: the autofill chamber as part of 900pt561 heated breathing tube and chamber kit 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 and videography provided by the customer, previous investigations of similar complaints, and our knowledge of the product.Results: visual inspection of the provided videography revealed that there was water leaking from the autofill chamber.Conclusion: without the return of the complaint device, we are unable to confirm the cause of the reported event.Every autofill chamber is pressure tested following the manufacturing process to check for any leaks present in the chamber.Any chamber that fails this test is rejected.The subject chamber would have met the required specification at the time of production.Our user instructions that accompany the 900pt561 heated breathing tube and chamber kit 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 china that an autofill chamber as part of the 900pt561 heated breathing tube and chamber kit was found leaking water.There were no reported patient consequences.

• Brand Name: HEATED BREATHING TUBE AND CHAMBER KIT
• Type of Device: AUTOFILL CHAMBER
• MDR Report Key: 18718115
• MDR Text Key: 336526692
• Report Number: 9611451-2024-00121
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K131895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Type of Report: Initial
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/10/2022
• 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