MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD AIRVO2 HUMIDIFIER

Model Number PT101

Device Problems Improper Flow or Infusion (2954); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 02/11/2019

Event Type  Death  

Manufacturer Narrative

(b)(4).The complaint pt101 airvo 2 humidifier is currently en route to fisher & paykel healthcare (b)(4) for further investigation.We will provide a follow up report upon the completion of our investigation.

Event Description

A distributor in (b)(4) reported on behalf of a healthcare facility that a patient was receiving nasal high flow therapy from a pt101 airvo2 humidifier for 3 days.It was reported that the flow from the cannula attached to the airvo was suddenly decreased.Sometime after the event occurred, the patient died while receiving therapy.Further information received from the customer indicated that there was no causal relationship between the death and the airvo.

Manufacturer Narrative

(b)(4).Supplementary information has been provided in a separate letter addressed to (b)(6) with fda reference number 9611451-2019-00245.Method: the complaint airvo 2 humidifier was received at fisher & paykel healthcare new zealand along with the heated breathing tube 900pt501, autofill chamber 900pt290, adult nasal cannula opt846 and water bag 900pt401.The returned device and accessories were visually inspected for defects and functionally tested by trained f&p personnel.Results: the unit was functionally tested at 30lpm and continued to operate during testing for three hours.No flow related issues were found and no errors or alarm warnings were generated.When the device was set to 30lpm the measured flow was 30.8lpm.Potential causes of the event as detailed in the product technical manual were assessed during the investigation.· the target flow was confirmed to be correct for the patient interface opt846.· the patient interface opt846 was inspected.The interface was not blocked or kinked and no other damage was identified.· the non-return valve was normal and was not displaced.· the returned 900pt290 chamber was tested for three hours and performed correctly.The device did not overfill above the black line.· the heated breathing tube was visually inspected.The tube was not blocked or kinked and no other damage was identified.· the airvo 2 humidifier log shows the device was set to default (adult) mode which is the correct mode for the patient based on the information provided by the customer.· there were no foreign objects blocking the air filter holder.The alarm mechanism was also tested as part of the investigation.If the flow is restricted below a limit then a visual and audible blockage alarm would be expected.This can occur in instances where the patient interface or heated breathing tube are blocked or kinked, if the non-return valve is damaged, if the incorrect mode is set or the wrong patient interface is used.The complaint airvo 2 humidifier was tested by simulating a blockage and it was confirmed that the blockage alarm was functioning correctly.Conclusion: f&p followed up with the customer to obtain more information related to this complaint event.The customer was asked to clarify the details including clarification on the reported malfunction of the airvo 2 humidifier, how it was detected, the settings of the airvo 2 humidifier and other devices used in the set-up.Further information on the patient was also requested including when the patient died in relation to the reported event.The customer stated that the airvo 2 humidifier was in default (adult) mode, set to 30lpm and delivering 80%fio2.The patient was receiving therapy from airvo 2 humidifier since they were admitted into the hospital (three days prior to the reported event) and they were set up with a bed side monitor for heart rate, spo2, blood pressure and respiratory rate.Staff at the hospital compared the flow coming from the tip of the cannula of the reported device to the flow of another device also set to 30lpm.Their comparison was performed by placing their hand at the tip of the cannula for each set up.The staff perceived the flow from the complaint device to be less than that from the comparative device based on the feel of the flow against their hands.Based on our analysis and the information provided by the customer on this event the airvo 2 humidifier along with the heated breathing tube 900pt501, autofill chamber 900pt290, adult nasal cannula opt846 and water bag 900pt401 performed as expected.The hospital also reported there was no causal relationship between the death of the patient and the airvo 2 humidifier.

Event Description

A distributor in (b)(4) reported on behalf of a healthcare facility that a patient was receiving nasal high flow therapy from a pt101 airvo2 humidifier for 3 days.It was reported that the flow from the cannula attached to the airvo was suddenly decreased.Sometime after the event occurred the patient died while receiving therapy.Further information received from the customer indicated that there was no causal relationship between the death and the airvo.

• Brand Name: AIRVO2 HUMIDIFIER
• Type of Device: AIRVO2 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: faranak gomarooni ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 8441413
• MDR Text Key: 139529300
• Report Number: 9611451-2019-00245
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012422323
• UDI-Public: 01094200124223231021004143601118021221180212065241
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2019
• 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: 2100414360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2018
• 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
• Patient Age: 86 YR