MAUDE Adverse Event Report: FISHER & PAYKEL AIRVO 2 HEATING BREATHING TUBE; HIGH FLOW BREATHING CIRCUIT

Model Number 900PT561

Device Problem Disconnection (1171)

Patient Problem Death (1802)

Event Date 07/01/2020

Event Type  Death  

Event Description

Inspiratory circuit became inadvertently disconnected during normal pt care.Disconnect was not noted until pt was in extremis.This was a high flow nasal cannula oxygen delivery system which had a device designed for the circuit which introduces neutralized medication.This device sits between the circuit and the patient nasal cannula.When the breathing circuit and the cannula are directly connected there is a locking mechanism, when the device for nebulized medication delivery is in place, there is no longer a locking mechanism.

• Brand Name: AIRVO 2 HEATING BREATHING TUBE
• Type of Device: HIGH FLOW BREATHING CIRCUIT
• Manufacturer (Section D): FISHER & PAYKEL
• MDR Report Key: 10521358
• MDR Text Key: 206706383
• Report Number: 10521358
• Device Sequence Number: 1
• Product Code: BTT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 07/30/2020,07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2020
• 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
• Distributor Facility Aware Date: 07/04/2020
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 82 YR
• Patient Weight: 85