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

Model Number PT101

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Fisher & paykel healthcare (f&p) is currently in the process of retrieving further information and the subject pt101 airvo 2 humidifier for evaluation.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported via a fisher and paykel (f&p) field representative that a few patients treated with pt101 airvo 2 humidifiers have developed a drug resistant bacterial infection, stenotrophomonas maltophilia.There was no further patient consequence reported.Further information has been requested from the healthcare facility.

Manufacturer Narrative

(b)(4).Method: the subject pt101 airvo 2 humidifiers were not returned to fisher & paykel healthcare (f&p) for evaluation, the healthcare facility reported on 28 december 2021 that there was no malfunction with the airvo 2 humidifiers.Our investigation is based on the information provided by the customer, our knowledge of the product and the medical literature.Results: the healthcare facility stated that a few patients treated with pt101 airvo 2 humidifiers developed a drug resistant bacterial infection, stenotrophomonas maltophilia.The customer stated that the airvo 2 humidifiers were cleaned and a disinfection cycle was performed on the devices before each new patient in accordance with our user instructions.The airvo 2 devices were used with the filters in place in accordance with our user instructions.Further information was requested from the healthcare facility regarding consequences to the patients, medical treatments and origin of the infection.The healthcare facility reported on 28 december 2021 that there was no malfunction with the airvo 2 humidifiers.No further information was provided.Conclusion: the transmission of stenotrophomonas maltophilia to susceptible individuals may occur through direct contact with a contaminated body or aerosols.During use of the pt101 airvo 2 humidifier, the interface, heated breathing tube, water chamber (single patient use accessories) and outlet elbow may become contaminated.The airvo 2 high level disinfection cycle consists of dry heated air circulating in the gas pathway, any stenotrophomonas maltophilia present in the outlet elbow would be killed by the disinfection cycle.The healthcare facility stated that the airvo 2 devices were used with the bacterial inlet filters in place.The bacterial inlet filter to the device is designed to filter out both bacteria and viruses.Based on the information received, there was no malfunction of the airvo 2 devices and no indication that the airvo 2 devices contributed to the reported bacterial infection.The airvo 2 user manual warns the user: "-ensure an air filter is fitted when operating your unit." "-the airvo 2 is not a sealed system.Follow hospital infection control guidelines to reduce risk of cross contamination." "-single-patient use accessories must be disposed of between patients to prevent cross-contamination" the disinfection kit manual (900pt600) states that "the airvo 2 humidifier must be cleaned and disinfected between patients.During use, the patient interface, heated breathing tube, water chamber and outlet elbow at the heated breathing tube connection port may become contaminated.It is particularly important that the outlet elbow at the heated breathing tube connection port is cleaned and disinfected properly.This should take place as soon as possible after use.".

Event Description

A healthcare facility in texas reported via a fisher and paykel (f&p) field representative that a few patients treated with pt101 airvo 2 humidifiers developed a drug resistant bacterial infection, stenotrophomonas maltophilia.Further information was requested from the healthcare facility regarding patient consequences, medical treatments and origin of the infection.The healthcare facility reported on 28 december 2021 that there was no malfunction with the airvo 2 humidifiers.No further information was provided.There were no further patient consequences reported.

• Brand Name: AIRVO 2 HUMIDIFIER
• Type of Device: AIRVO 2 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: 12791835
• MDR Text Key: 280680986
• Report Number: 9611451-2021-01270
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/12/2021

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2021
• Initial Date FDA Received: 11/10/2021
• Supplement Dates Manufacturer Received: 01/20/2022
• Supplement Dates FDA Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other