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

Model Number PT101

Device Problem Moisture Damage (1405)

Patient Problems Death (1802); Pneumonia (2011)

Event Date 01/22/2015

Event Type  malfunction  

Event Description

A hospital in the (b)(6) reported that condensation formed in a 900pt501 heated breathing tube used with an airvo humidifier and the patient aspirated some condensate.No further patient consequence was reported with regard to this incident.We were informed by the hospital that the patient later died.The hospital has confirmed that the cause of death was pneumonia and that use of the airvo system was not a contributing factor.

Manufacturer Narrative

(b)(4).The airvo is a humidifier with integrated flow generator that delivers warmed and humidified respiratory gases to spontaneously breathing patients through a variety of patient interfaces.The complaint airvo humidifier was not returned to fisher & paykel healthcare (fph) for evaluation but it is still in service at the hospital.The hospital informed us that they had destroyed the complaint breathing circuit, but there was no suggestion that the circuit malfunctioned in any way.Following this complaint, fph field representatives visited the hospital to provide further education on condensate management and to gather more details.We were informed that: the patient was on optiflow therapy with the airvo and an optiflow nasal cannula.The patient was prone (lying down) and the airvo and chamber was higher than the patient's head.The patient aspirated some condensate and optiflow therapy was subsequently stopped.The patient died a few hours later and at this stage had been off optiflow therapy for a few hours.The hospital has confirmed that they are satisfied that the airvo was not the cause of death.The cause of patient death was pneumonia.Conclusion: based on the description of events it appears likely that condensation had built up in the heated breathing tube and had not been cleared by staff.The placement of the airvo humidifier and accompanying water chamber above the patient's head would have increased the probability of condensate entering the patient's air path.Our user instructions advise the user that the "airvo 2 should be fixed on a pole mounting tray (900pt405) below patient head height." our user instructions that accompany the airvo humidifier state that "if excess condensation accumulates in the heated breathing tube, drain by lifting the patient end of the tube, allowing the condensate to run into the water chamber." in addition we have recently provided guidance for hospitals to assist with condensate management.This guidance is contained in the airvo troubleshooting guide and states the following: if condensation is present, drain it back into the water chamber.- disconnect the patient interface from the heated breathing tube.Drain the tube by lifting the patient end of the tube, allowing the condensate to run into the water chamber.At higher target flow rates, it may be necessary to first reduce the target flow rate to 30 l/min or below, to ensure the condensate drains into the water chamber.The airvo 2 user manual instructs the user to "use continuous oxygen monitoring on patients who would desaturate significantly in the event of disruption to their oxygen supply." the user manual also states that the "airvo 2 is for the treatment of spontaneously breathing patients who would benefit from receiving high-flow, warmed and humidified respiratory gases." and that "the unit is not intended for life support.".

• 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: raymond yan ; 15365 barranca parkway; irvine, CA 92618-2216 ; 9494534000
• MDR Report Key: 4529132
• MDR Text Key: 5544206
• Report Number: 9611451-2015-00099
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Physical Therapist
• Type of Report: Initial
• Report Date: 01/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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
• Date Manufacturer Received: 01/23/2015
• 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: Reuse
• Patient Sequence Number: 1
• Treatment: FISHER & PAYKEL 900PT501 ADULT TUBE & CHAMBER KIT