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

Model Number 900PT561

Device Problem Overfill (2404)

Patient Problem Aspiration/Inhalation (1725)

Event Date 06/06/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Fisher & paykel healthcare (f&p) have requested further information and 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 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.

Event Description

A healthcare facility in china reported that the autofill chamber as part of the 900pt561 heated breathing tube and chamber kit was found to have overfilled above the maximum water level line, causing the patient to aspirate on water.The subject device was then replaced and no further patient consequences were reported.Fisher & paykel healthcare (f&p) have requested further infromation about the event and patient condition.

Event Description

A healthcare facility in china reported that the autofill chamber as part of the 900pt561 heated breathing tube and chamber kit was found to have overfilled above the maximum water level line, causing the patient to aspirate on water.The subject device was then replaced and no further patient consequences were reported.

Manufacturer Narrative

(b)(6).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.F&p made multiple requests for the return of the device and further information from the healthcare facility, including the sequence of events, photographs, diagrams of the device set up, etc.However, the device was not returned, and no response was provided.Therefore, our investigation is based on the initial 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 had overfilled above the maximum water level line causing the patient to aspirate on water.The subject device was replaced and no further patient consequences were reported.Conclusion: without additional information, photographs, or 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 feed set due to cracks and other causes.Any chamber that fails this inspection is rejected.The subject chamber would have met the required specification at the time of production.The user instructions that accompany the 900pt561 heated breathing tube and chamber kit show in pictorial format the correct placement, fitting, and water level for the autofill chamber.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.".

• Brand Name: HEATED BREATHING TUBE AND CHAMBER KIT
• 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 92613 ; 8007923912
• MDR Report Key: 17553667
• MDR Text Key: 321329725
• Report Number: 9611451-2023-00758
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012433794
• UDI-Public: (01)09420012433794(10)2102045572(11)220221
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K131895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/17/2023

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: 2102045572
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/17/2023
• Initial Date FDA Received: 08/15/2023
• Supplement Dates Manufacturer Received: 08/23/2023
• Supplement Dates FDA Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2022
• 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
• Patient Age: 83 YR
• Patient Sex: Male