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

Model Number 900PT561

Device Problems Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Low Oxygen Saturation (2477)

Event Date 01/11/2022

Event Type  Death  

Event Description

A healthcare facility in france reported, via a fisher & paykel healthcare (f&p) field representative, that on (b)(6) 2022 a geriatric covid-19 patient with severe respiratory failure was found non-responsive at 6pm and medical staff were alerted.It was reported that the pt101 airvo 2 humidifier (airvo 2) was alarming for blockage, the patient was hypoxic and assessed to have a glasgow coma scale score of 3.The healthcare facility reported that the heated breathing tube (hbt) as part of a 900pt561 heated breathing tube and chamber kit was found bent under the patient's arm.Removal of the hbt from under the patient's arm resolved the airvo 2 alarm and flow immediately resumed.The patient's condition did not improve and they were declared deceased at 6.45pm.The healthcare facility reported that the patient was not bedridden.The healthcare facility stated that it was possible that the patient got out of bed and when they returned to bed, accidentally bent the hbt under their arm.It was further reported by the healthcare facility that there was no malfunction with the airvo 2 system as the airvo 2 device alarmed as intended.Further information has been requested from the healthcare facility regarding the sequence of events and the medical cause of death.

Manufacturer Narrative

(b)(4).The healthcare facility has discarded the subject 900pt561 heated breathing tube and chamber kit and so it cannot be returned to fisher & paykel healthcare (f&p) for evaluation.F&p are currently in the process of retrieving further information regarding the reported event including the sequence of events and medical cause of death.We will provide a follow up report upon completion of our investigation.Product background: the heated breathing tube and chamber kit is a component designed for use with the airvo 2 series of humidification devices.It consists of a 3-dimensional bubble tube wall construction with embedded heater wires.It is used to deliver humidified oxygen to patients including patients receiving nasal high flow therapy (nhf).The chamber humidifies the air and oxygen and delivers it to the heated breathing tube, the heated breathing tube heated by the heater wire, transfers the humidified air to the patient interface.Nhf therapy and the airvo 2 device are intended for use with 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.

Manufacturer Narrative

(b)(4).Product background: the heated breathing tube and chamber kit is a component designed for use with the airvo 2 series of humidification devices.It consists of a 3-dimensional bubble tube wall construction with embedded heater wires.It is used to deliver humidified oxygen to patients including patients receiving nasal high flow therapy (nhf).The chamber humidifies the air and oxygen and delivers it to the heated breathing tube, the heated breathing tube heated by the heater wire, transfers the humidified air to the patient interface.Nhf therapy and the airvo 2 device are intended for use with 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 healthcare facility discarded the subject (b)(6) heated breathing tube and chamber kit and so it could not be returned to fisher & paykel healthcare (f&p) for evaluation.Further information regarding the reported event was requested from the healthcare facility, however the healthcare facility was only able to provide limited information.An investigation was carried out by f&p which was based on the information provided by the healthcare facility and our knowledge of the product.Results: the healthcare facility provided the following sequence of events: on (b)(6) 2022, a geriatric covid-19 patient with severe respiratory failure was admitted to the geriatric ward and provided nhf therapy after the resus unit advised the patient did not need to be admitted to the resus unit or icu.At 6pm on the same day, the patient was found to be non-responsive and medical staff were alerted.The patient was hypoxic and assessed to have a glasgow coma scale score of 3 (completely non-responsive).The healthcare facility reported that the airvo 2 generated a "check for blockages" alarm and the hbt was found bent under the patient's arm.The hbt was removed from under the patient's arm and repositioned, which resolved the "check for blockages" alarm and allowed for air flow to resume immediately.However, the patient's condition did not improve and they were declared deceased at 6.45pm.The medical cause of death was not provided by the healthcare facility despite several attempts to request for this.The healthcare facility reported that the patient was not bedridden and it is possible that the patient got out of bed and accidentally bent the hbt under their arm when they returned to bed.The healthcare facility confirmed that there was no malfunction with the airvo 2 system as the airvo 2 device alarmed for blockage as intended.The healthcare facility further reported that the ward was under-staffed and under-equipped, and so the patient was not appropriately monitored.The healthcare facility reported that the ward has since implemented oxygen saturation monitoring for all patients using airvo 2 devices.Conclusion: there was no alleged malfunction with the hbt as part of the 900pt561 heated breathing tube or with the airvo 2 system.Based on our knowledge of the product and the information provided by the healthcare facility, the reported event was most likely caused by the application of an external weight (i.E.The patient's arm) on the subject hbt, resulting in a blockage and therefore a loss of air flow.The airvo 2 device alarmed as intended to alert clinical staff to the blockage in the system.It was also noted that appropriate patient monitoring was not in place.A "check for blockages" alarm, which includes both visual and audible alerts, is a result of the airvo 2 detecting a blockage in the system that would prevent the device from reaching the desired air flow.A blockage may occur anywhere in the gas path, from the device unit to the patient interface.While in alarm state the device attempts to continue to supply the required flow rate while continuously monitoring the restriction in the gas path.The alarm, both audio and visual, will continue until the blockage is cleared, and the required flow is once again achieved.The airvo 2 user manual provides trouble shooting guidance for the said alarm state, these include checking the following: - check the heated breathing tube or patient interface for blockage.Check the air filter and filter holder for blockage.All hbts as part of the 900pt561 heated breathing tube and chamber kits are visually inspected and undergo functional tests, including soak and temperature, and heater wire resistance.The subject hbt would have met the required specifications.The 900pt561 heated breathing tube and chamber kit user instructions show in pictorial format the correct placement of the device and includes the following information:"do not block the flow of air through the unit and breathing tube." - "never operate the unit if the breathing tube has been damaged with holes, tears or kinks" the airvo 2 humidifier user manual also states:"airvo 2 is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases" - "the unit is not intended for life support." "use continuous oxygen monitoring on patients who would desaturate significantly in the event of disruption to their oxygen supply." "prior to each patient use, ensure that the auditory alarm signal is audible by conducting the alarm system functionality check described in the alarms section." the f&p field representative has since met with representatives from the healthcare facility to discuss plans for further education and training regarding the correct set-up and use of the hbt and airvo 2 system.

Event Description

A healthcare facility in france reported via a fisher & paykel healthcare (f&p) field representative, that on (b)(6) 2022 a geriatric covid-19 patient with severe respiratory failure was found non-responsive at 6pm and medical staff were alerted.It was reported that the pt101 airvo 2 humidifier (airvo 2) was alarming for blockage, the patient was hypoxic and assessed to have a glasgow coma scale score of 3 (completely non-responsive).The healthcare facility reported that the heated breathing tube (hbt) as part of a 900pt561 heated breathing tube and chamber kit was found bent under the patient's arm.Removal of the hbt from under the patient's arm resolved the airvo 2 alarm and flow immediately resumed.The patient's condition did not improve and they were declared deceased at 6.45pm.The healthcare facility reported that the patient was not bedridden.The healthcare facility stated that it was possible that the patient got out of bed and when they returned to bed, accidentally bent the hbt under their arm.The healthcare facility confirmed that there was no malfunction with the hbt or airvo 2 system and the airvo 2 device alarmed as intended.Further information, including the medical cause of death, was requested from the healthcare facility.However, the healthcare facility was only able to provide limited information.

• Brand Name: HEATED BREATHING TUBE AND CHAMBER KIT
• 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 LTD; 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: 14782536
• MDR Text Key: 294563927
• Report Number: 9611451-2022-00522
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K162553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 900PT561
• Device Catalogue Number: 900PT561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/04/2022
• 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?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: F&P PT101 AIRVO 2 HUMIDIFIER; F&P PT101 AIRVO 2 HUMIDIFIER
• Patient Outcome(s): Death
• Patient Age: 75 YR