MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD OPTIFLOW + ADULT NASAL CANNULA; BTT

Model Number OPT944

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 04/23/2022

Event Type  Death  

Manufacturer Narrative

(b)(4).The opt944 optiflow + adult nasal cannula is a nasal cannula patient interface for delivery of humidified respiratory gases, including those who are receiving nasal high flow therapy.Nhf therapy is intended for use with spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.The airvo 2 device should not be used for life support purposes, and appropriate patient monitoring must be used at all times.It consists of a lightweight delivery tube connected to a rigid plastic base and soft nasal prongs (nasal interface).This allows the device to be light weight and durable.The interface is held in place by a head strap and features a head strap clip which works in tandem with the tubing clip (attaches to the patient's clothing/bedding) to support the weight of the circuit and prevent the cannula being dislodged.Optiflow + interfaces are designed for use with the airvo 2 series of humidification devices.Fisher & paykel healthcare (f&p) has requested for the complaint device to be returned 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 & paykel healthcare (f&p) field representative that the tubing of an opt944 optiflow + adult nasal cannula was found broken at the connector after 5 days use.It was also reported that the patient deceased.It was further reported that the patient was critically ill with pneumonia, disorientated and they removed the cannula a couple of times during use.The patient had a do not resuscitate order in place.The medical cause of death was hypoxic lung failure and non-specific bacterial pneumonia.

Manufacturer Narrative

(b)(4).The opt944 optiflow + adult nasal cannula is a nasal cannula patient interface for delivery of humidified respiratory gases, including those who are receiving nasal high flow therapy.Nhf therapy is intended for use with spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.The airvo 2 device should not be used for life support purposes, and appropriate patient monitoring must be used at all times.It consists of a lightweight delivery tube connected to a rigid plastic base and soft nasal prongs (nasal interface).This allows the device to be light weight and durable.The interface is held in place by a head strap and features a head strap clip which works in tandem with the tubing clip (attaches to the patient's clothing/bedding) to support the weight of the circuit and prevent the cannula being dislodged.Optiflow + interfaces are designed for use with the airvo 2 series of humidification devices.Method: the complaint opt944 optiflow + adult nasal cannula and 900pt561 heated breathing tube were returned to fisher & paykel healthcare (f&p) new zealand for investigation, where they were inspected.An investigation was carried out by f&p which was based on the information provided by the healthcare facility, our evaluation of the returned devices, and our knowledge of the product.Results: the healthcare facility reported the following sequence of events: a critically ill patient with pneumonia and hypoxic lung failure was admitted to hospital on the (b)(6) 2022.On (b)(6) 2022 it was decided not to resuscitate the patient if their condition worsened.The patient had alot of anxiety and removed the cannula a couple of times during use.There was no patient monitoring in place.Five days later on the (b)(6) 2022 the patient was found unconscious, the opt944 was found damaged.The healthcare facility stated the medical cause of death was pneumonia and hypoxic lung failure.Visual inspection of the returned opt944 optiflow + adult nasal cannula revealed the tubing was detached from the 3-way connector.Measurements confirmed the dimensions of the swivel were within specification.There was no damage to the 900pt561 heated breathing tube.Conclusion: our investigation was unable to determine the cause of the observed damage to the opt944 optiflow + adult nasal cannula.However, based on our knowledge of the product, the reported damage is likely to have been caused by the tubing being subjected to excessive force during use.This is supported by the healthcare facility's report that the subject device had already been in use for five days and the patient removed the cannula a couple of times.The medical cause of death was pneumonia and hypoxic lung failure.Manufacturing controls include inspections during production for visual defects to the optiflow + tubing and the swivel, including cracks, tears, moulding defects, contamination, inclusions, discoloration and stretching or deformation.The optiflow + tubing is also inspected for any assembly defects, including confirmation the swivel and 3-way connector are connected with the correct engagement.Any product that fails the visual inspection is disposed of.The subject opt944 optiflow + adult nasal cannula would have met the required specifications.The user instructions which accompany the opt944 optiflow + adult nasal cannula show in pictorial format the correct placement and fitting of the cannula, including ensuring the headstrap clip and the tubing clip are appropriately attached.The user instructions also warn: - "ensure head strap clip is attached, to prevent cannula from being pulled out of the nares." - "cannula can become unattached if not used with the head strap clip." - "attach tubing clip to clothing/bedding to prevent cannula from pulling off face." - "appropriate patient monitoring must be used at all times.Failure to monitor the patient may result in loss of therapy, serious injury or death." - "do not crush or stretch tube, to prevent loss of therapy." - "failure to use the set-up described above can compromise performance and affect patient safety.".

Event Description

A healthcare facility in sweden reported via a fisher & paykel healthcare (f&p) field representative that the tubing of an opt944 optiflow + adult nasal cannula was found broken at the connector after 5 days use.It was also reported that the patient deceased.It was further reported that the patient was critically ill with pneumonia, disorientated and they removed the cannula a couple of times during use.The patient had a do not resuscitate order in place.The medical cause of death was hypoxic lung failure and non-specific bacterial pneumonia.

• Brand Name: OPTIFLOW + ADULT NASAL CANNULA
• Type of Device: BTT
• 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 ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534002
• MDR Report Key: 14520215
• MDR Text Key: 292785570
• Report Number: 9611451-2022-00431
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012429117
• UDI-Public: (01)09420012429117(10)2101213160(11)200723
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K162553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OPT944
• Device Catalogue Number: OPT944
• Device Lot Number: 2101213160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: F&P 900PT561 HEATED BREATHING TUBE AND CHAMBER KIT; F&P 900PT561 HEATED BREATHING TUBE AND CHAMBER KIT; F&P PT101 AIRVO 2 HUMIDIFIER; F&P PT101 AIRVO 2 HUMIDIFIER
• Patient Outcome(s): Death
• Patient Age: 82 YR
• Patient Sex: Female