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

Model Number 900PT561

Device Problems Crack (1135); Gas/Air Leak (2946)

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

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 received at fisher & paykel healthcare (f&p) for investigation, where it was inspected by a trained f&p employee.Our investigation is based on our evaluation of the subject device, the information provided by the customer, previous investigations of similar complaints, and our knowledge of the product.Results: inspection of the returned autofill chamber revealed severe cracks in the chamber on the side and around one of the ports of the chamber.Further cracks and stress marks were found on the chamber dome.Conclusion: we are unable to determine the exact cause of the damage to the autofill chamber.Our investigation indicates that the damage was due to mechanical stress.The stress source was unable to be identified.Every autofill chamber is pressure tested following the manufacturing process to check for any leaks present in the chamber 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.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 an issue with an autofill chamber as part of the 900pt561 heated breathing tube and chamber kit.During device evaluation and performance testing at our fisher & paykel healthcare (f&p) in new zealand, it was found with chamber cracks.There was no patient involvement as the issue was found whilst the device was not in use on a patient.

• 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: 18323734
• MDR Text Key: 330468328
• Report Number: 9611451-2023-01150
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012433794
• UDI-Public: (01)09420012433794(10)210208(11)0711220314
• 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: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2023
• 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: 2102081107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2022
• 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