MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD AIRVO 2 HUMIDIFIER; RESPIRATORY HUMIDIFIER

Model Number PT101

Device Problems Inaccurate Flow Rate (1249); Insufficient Information (3190)

Patient Problem Low Oxygen Saturation (2477)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Fisher & paykel healthcare (f&p) has requested for the complaint device be returned and requested for additional information for evaluation.We will provide a follow up report upon completion of our investigation.Product background: the opt944 optiflow + adult nasal cannula is a nasal cannula patient interface for delivery of humidified respiratory gases, including those who are receiving nasal high flow therapy (nhf).The cannula consists of a lightweight delivery tube connected to a rigid plastic base and soft nasal prongs (nasal interface).This allows the device to be light weight and durable.The interface is held in place by a head strap and features a head strap clip which works in tandem with the tubing clip (attaches to the patient's clothing/bedding) to support the weight of the circuit and prevent the cannula being dislodged.Optiflow + interfaces are designed for use with the airvo series humidifiers and are also compatible with the fisher & paykel healthcare (f&p) mr850 and 950 humidification system devices.Optiflow + interfaces are intended for use with spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.Optiflow + interfaces are not intended for life support and appropriate patient monitoring must be used at all times.

Event Description

A healthcare facility in australia reported via a fisher and paykel healthcare (f&p) field representative on (b)(6) 2023 that a pt101 airvo 2 humidifier fraction of inspired oxygen (fio2) displayed on the subject device was not the same as the actual fio2 received by the patient.Further information provided on (b)(6) 2023 by the healthcare facility stated that the patient desaturated to 83% spo2.Replacement of the subject device, including the circuit, resulted in a rapid improvement of the patients spo2 levels.However, the healthcare facility further stated that the patient was later admitted to the icu.Further follow up on the patients current condition, the healthcare facility stated the patient has since deceased.Fisher & paykel healthcare (f&p) has requested for the complaint device be returned and requested for additional information for evaluation.We will provide a follow up report upon completion of our investigation.

Manufacturer Narrative

Ps436384.Product background: the pt101 airvo 2 humidifier (airvo 2) device is an active humidifier with integrated flow generator that delivers high flow warmed and humidified respiratory gases to spontaneously breathing patients through a variety of patient interfaces.Its intended use is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.The airvo 2 device should not be used for life support purposes, and appropriate patient monitoring must be used at all times.Method: the subject airvo 2 device was received at fisher & paykel healthcare (f&p) in new zealand for investigation, where it was visually inspected and performance tested by a trained f&p investigation engineer.F&p's investigation is based on f&p's evaluation of the subject airvo 2 device, information provided by the healthcare facility, previous investigations of similar complaints, and f&p's knowledge of the product.Results: f&p received the subject airvo 2 device that was returned and has completed its investigation.The subject airvo 2 device was visually inspected by a trained f&p investigation engineer and there was no evidence of visible damage.The subject airvo 2 device was tested continuously by a trained f&p investigation engineer for an extended period of time and ran without any errors.The subject airvo 2 device was found to be working properly.The subject airvo 2 device was also tested with oxygen entrained.This testing showed that the subject airvo 2 device was operating within design limits.No faults were found on the subject airvo 2 device during testing, and f&p was unable to replicate the fault.Based on the reported follow-up information provided by the healthcare facility, the patient recovered after the initial event and the subject airvo 2 device was no longer used after the event.The healthcare facility reported that the patient had multiple comorbidities.The healthcare facility stated that the subject airvo 2 device was in use on the patient for no more than 15 minutes and that the patient desaturation was observed during routine observation of the patient.The patient desaturated to 83% spo2 and the healthcare facility reported that the desaturation was managed by using a non-rebreather mask and high flow nasal prongs (hfnp).The replacement of the subject airvo 2 device, including the circuit, resulted in a rapid improvement of the patients spo2 levels, however, the fio2 reading from the new device remained consistent with the reading from the subject airvo 2 device.The healthcare facility reported that no alarms were triggered on the subject device at the time of the event.The healthcare facility also reported that the patient had deceased four days after the event with the subject airvo 2 device and that the medical cause of the patient death was pneumonia.Conclusion: f&p's investigation was unable to determine the exact cause of the reported event.Although f&p is unable to determine the exact cause of the reported event, based on the available information from the healthcare facility and f&p's investigation on the subject airvo 2 device, there is no conclusive evidence of a causal relationship between the reported event and the patient death.Based on f&p's knowledge of the product, the airvo 2 does not have control over the oxygen being delivered to the patient, but rather, it is equipped with an oxygen analyzer to help the user determine the oxygen fraction being delivered to the patient.The airvo 2 is designed to blend oxygen with room air and measure fio2, when delivering nasal high flow therapy.The airvo 2 does not control the volume of oxygen delivered.The volume of oxygen delivered is titrated using an oxygen flow meter and controlled by healthcare professionals.Hence, the changes in flow rate on the airvo 2 do not affect the volume of oxygen being delivered.During the manufacturing process, quality control measures ensure each manufactured airvo 2 meets specifications.The following specific controls ensure each device delivers flow as per the device performance specifications and that the unit is free from any physical damage: visual examination: each unit is visually inspected for external damage and rejected if any damage is identified.Pressure flow testing: each unit is pressure tested and flow and oxygen measurements are verified to ensure there are no leaks in the airpath.Soak and reliability testing: each unit is connected to a heated breathing tube (hbt) and water chamber, and then tested to ensure it performs as intended over extended operating conditions.These quality control measures are performed at the end of the final assembly process on 100% of the manufactured units.Any unit that fails any of these tests will be rejected.The subject airvo 2 device would have met the required specifications at the time of release.The airvo 2 humidifier user instructions also states: "the oxygen concentration delivered to the patient can be affected by changes to the flow setting, oxygen setting, patient interface or if the airpath is obstructed." "do not connect supplementary oxygen to the airvo 2 at flow rates higher than the airvo 2 target flow rate, as excess oxygen will be vented into the surroundings, or 60l/min." "note that if the patient's peak inspiratory demand exceeds the flow delivered by the unit, the fraction of oxygen inspired by the patient will be lower than the value shown onscreen, due to additional entrainment of ambient air.".

Event Description

A healthcare facility in melbourne reported via a fisher and paykel healthcare (f&p) field representative on (b)(6) 2023 that the fraction of inspired oxygen (fio2) displayed on a pt101 airvo 2 humidifier was not the same as the actual fio2 received by the patient.The subject device was replaced, and the fio2 reading from the new device remained consistent with the reading from the subject airvo 2 device.Further information provided on (b)(6) 2023 by the healthcare facility stated the subject airvo 2 device was in use on the patient for no more than 15 minutes and that the patient desaturation was observed during routine observation of the patient.The patient desaturated to 83% spo2 which was managed by using a non-rebreather mask and high flow nasal prongs (hfnp).The healthcare facility reported that replacement of the subject airvo 2 device, including the circuit, resulted in a rapid improvement of the patients spo2 levels.However, the fio2 reading from the new device remained consistent with the reading from the subject airvo 2 device.There were no alarms triggered on the subject airvo 2 device at the time of the event.The healthcare facility further stated that the patient was later admitted to the icu.The healthcare facility provided further information on (b)(6) 2024 stating that the patient had multiple comorbidities such as acute myelogenous leukemia and had undergone lung transplantation.The healthcare facility also reported that the patient had deceased four days after the event with the subject airvo 2 device and that the medical cause of the patient death was pneumonia.

• Brand Name: AIRVO 2 HUMIDIFIER
• Type of Device: RESPIRATORY HUMIDIFIER
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 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: 18378889
• MDR Text Key: 331175365
• Report Number: 9611451-2023-01198
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K131895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PT101
• Device Catalogue Number: PT101
• Device Lot Number: 2101786993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2023
• Initial Date FDA Received: 12/21/2023
• Supplement Dates Manufacturer Received: 01/15/2024
• Supplement Dates FDA Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other
• Patient Age: 65 YR