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 No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

A healthcare facility in taiwan reported via a fisher & paykel healthcare (f&p) field representative that the autofill chamber as part of the 900pt561 heated breathing tube and chamber kit was found to have overfilled during use.There were no reported patient consequences.

Manufacturer Narrative

Ps426213 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 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.

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 received at fisher & paykel healthcare (f&p) for investigation, where it was visually inspected and tested.Results: inspection of the returned autofill chamber found no fault with the subject device.Conclusion: our investigation was unable to determine the cause of the over-filling autofill chamber as there was no fault found with the returned device.Overfilling of water can be caused by the primary float mechanisms in the autofill chamber being disabled.In circumstances where the primary float is disabled, the water may overfill above the black water level line of the chamber.However, the secondary float will serve as a backup to prevent the water from overflowing outside the chamber port and entering the breathing circuit.During the manufacturing process every autofill chamber has the functionality of the primary and secondary floats tested both during sub-assembly of the float mechanisms and once fully assembled into the autofill chamber.If either float fails during these tests the devices are rejected.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.".

Event Description

A healthcare facility in taiwan reported via a fisher & paykel healthcare (f&p) field representative that the autofill chamber as part of the 900pt561 heated breathing tube and chamber kit was found to have overfilled during use.There were no reported patient consequences.

• 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 92618 ; 8007923912
• MDR Report Key: 17410655
• MDR Text Key: 320476676
• Report Number: 9611451-2023-00706
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012433794
• UDI-Public: (01)09420012433794(10)2102142052(11)220420
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K131895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/30/2023

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: 2102142052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/30/2023
• Initial Date FDA Received: 07/27/2023
• Supplement Dates Manufacturer Received: 10/04/2023
• Supplement Dates FDA Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2022
• 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
• Treatment: F&P PT101 AIRVO 2 HUMIDIFIER.; F&P PT101 AIRVO 2 HUMIDIFIER.