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

Model Number 900PT290E

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

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

Event Date 06/05/2023

Event Type  malfunction  

Event Description

A healthcare facility in china reported that the 900pt290e autofill chamber with adapter as part of the 900pt561 heated breathing tube and chamber kit was found leaking water during use.There was no patient consequence.

Manufacturer Narrative

(b)(4).Product background: the 900pt290e chamber (900pt290e) as part of the 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 900pt290e was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the information provided by the customer, previous investigations of similar complaints, and our knowledge of the product.Results: the customer reported that the 900pt290e had a leak during ten minutes of patient use.However, the customer also stated that the subject device has been reused.Conclusion: without the return of the complaint device, we are unable to confirm the cause of the reported event.However, the customer stated that the subject device was reused, which is outside of the intended use.Every 900pt290e 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.Our user instructions that accompany the 900pt561 heated breathing tube and chamber kit state the following: - "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." - "do not use the auto-fill mr290 chamber if it has been dropped or been allowed to run dry" - "do not use the mr290 chamber if the water level rises above the maximum water level line" - "avoid contact with chemicals, cleaning agents, or hand sanitizers.".

• 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 ; 9494534000
• MDR Report Key: 17303359
• MDR Text Key: 319199177
• Report Number: 9611451-2023-00642
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2023
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: F&P 900PT561 HEATED BREATHING TUBE AND CHAMBER KIT; F&P PT101 AIRVO 2 HUMIDIFIER
• Patient Age: 82 YR