MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD AUTOFILL CHAMBER; BTT

Model Number 900PT290E

Device Problem Degraded (1153)

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

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 900pt290e autofill chamber with adapter (900pt290e) 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 china that a 900pt290e autofill chamber was found with holes in the chamber base.There were no reported patient consequences.

Event Description

A distributor reported on behalf of a healthcare facility in china that a 900pt290e autofill chamber was found with holes in the chamber base.There were no reported patient consequences.

Manufacturer Narrative

(b)(4).Product background: the (b)(4) autofill chamber with adapter (900pt290e) 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 (b)(4) was received at fisher & paykel healthcare (f&p) for investigation, where it was visually inspected.Further information about the reported event was requested from the customer, however, no response was provided.Our investigation is based on our evaluation of the subject device, the initial information provided by the customer, previous investigations of similar complaints, and our knowledge of the product.Results: visual inspection of the returned (b)(4) revealed that the chamber was contaminated with deposits on the inside of the chamber dome and base, there were several holes in the aluminium base of the chamber.Conclusion: without further information about the event, our investigation is unable to determine the cause of the observed damage to the 900pt290e.Based on our knowledge of the product, the chamber was likely exposed to a solution other then sterile water, causing the base to corrode.The user instructions that accompany the 900pt290e as part of the 900pt561 heated breathing tube and chamber kit state "use only usp sterile/distilled water for inhilation, or equivalent.".Our user instructions also state the following: "this product is not intended for use with any medication"."this product is inteded o be used for a maximum of 14 days."."do not soak, wash or sterilize."."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.".Every 900pt290e is tested following the manufacturing process to check for any defects present in the chamber.Any chamber that fails this inspection is rejected.The subject chamber would have met the required specification at the time of production.

• Brand Name: AUTOFILL CHAMBER
• Type of Device: BTT
• 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: faranak gomarooni ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534002
• MDR Report Key: 16756078
• MDR Text Key: 313524063
• Report Number: 9611451-2023-00332
• Device Sequence Number: 1
• Product Code: BTT
• 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,User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/21/2023

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: 900PT290E
• Device Catalogue Number: 900PT290E
• Device Lot Number: 220209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2023
• Initial Date FDA Received: 04/17/2023
• Supplement Dates Manufacturer Received: 05/16/2023
• Supplement Dates FDA Received: 05/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2022
• 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 900PT561 HEATED BREATHING TUBE AND CHAMBER KIT; F&P 900PT561 HEATED BREATHING TUBE AND CHAMBER KIT; F&P PT101 AIRVO 2 HUMIDIFIER; F&P PT101 AIRVO 2 HUMIDIFIER