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

Model Number PT101

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Death (1802); Pneumothorax (2012); Multiple Organ Failure (3261)

Event Date 07/31/2014

Event Type  Death  

Event Description

A hospital in (b)(6) reported that a patient had died on (b)(6) 2014.Prior to the incident the patient had been on nasal high flow (optiflow) therapy using a pt101 airvo humidifier.After 48 hours of optiflow treatment, the patient was reported to have developed a pneumomediastinum (air in the cavity between the lungs).It was further reported that the patient was using a high concentration oxygen mask system for 14 days prior to being put on the optiflow system.The patient was over (b)(6) years old.We were informed that the cause of death was multiple organ dysfunction syndrome (mods) without any single cause identified.

Manufacturer Narrative

(b)(4).Neither the opt844 nasal interface nor the airvo2 humidifier were returned to fisher & paykel healthcare for evaluation.The hospital has not alleged any defect with either the airvo2 humidifier or the opt844 nasal interface., and the hospital continues to use the airvo2 humidifier.Our investigation is accordingly based on the description of events and our knowledge of the products and the optiflow therapy.Upon receipt of this complaint, additional information, including cause of death, was sought from the hospital.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 opt844 interface is used to deliver humidified oxygen to patients.It consists of a lightweight delivery tube which is connected to a rigid plastic base and soft nasal prongs (nasal interface).The interface is held in place by a head strap and also includes a lanyard which is placed around the patient's neck or attached to the patient's clothing or bedding to remove the load of the breathing circuit from the patient's nares.The hospital has reported that the patient developed pneumomediastinum and subsequently died.There is no evidence to suggest that the patient's death was caused by the opiflow therapy, the cause of death having been reported as multiple organ dysfunction syndrome.With optiflow, the patient is being supported with pressures which would have been significantly lower than when the patient was ventilated with a ventilator or cpap therapy.Airway pressures of around 30cmh2o are typical with use of a ventilator, whereas optiflow pressures are typically around 3 to 4cmh2o.There are many non-optiflow related reasons which could have resulted in a pneumomediastinum.For example, it is possible that the patient developed a spontaneous pneumomediastinum which was associated with severe pathophysiology of the lungs.It was reported that the patient had pneumocystosis.This is the only complaint of this nature we have received for the optiflow system.

• 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: 4062297
• MDR Text Key: 4813430
• Report Number: 9611451-2014-00749
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Physician
• Type of Report: Initial
• Report Date: 08/06/2014

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: 08/06/2014
• Initial Date FDA Received: 09/05/2014
• 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 OPT844 ADULT NASAL CANNULA
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 80 YR