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

Model Number MYOPT9MEDIUM

Device Problem Disconnection (1171)

Patient Problem Insufficient Information (4580)

Event Date 06/23/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product background: the myopt9medium is a nasal cannula patient interface for delivery of humidified respiratory gases, including those who are receiving nasal high flow therapy (nhf).Optiflow + interfaces are designed for use with the myairvo 2 series of humidification devices.Nhf therapy and the myairvo 2 device are intended for use with spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.The myairvo 2 device should not be used for life support purposes and appropriate patient monitoring must be used at all times.The cannula 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.Fisher & paykel healthcare (f&p) has requested further information regarding the reported event including the device setup, sequence of events, the relevant medical history and medical cause of death.Furthermore, the complaint myopt9medium optiflow + adult nasal cannula and myairspiral heated breathing tube are currently en route to f&p for evaluation.We will provide a follow up report upon completion of our investigation.

Event Description

A distributor in japan reported on the morning of (b)(6) 2022, it was discovered that the patient was not breathing and it was reported that the myoepithelium optiflow+ nasal cannula was found disconnected from the myairspiral heated breathing tube when in use with the myairvo2.From the (b)(6) 2022 the patient had been using oxygen during the day and switched to myairvo 2 at night at home, with no problems with the myairvo 2.The patient had advanced stage colon cancer, non-tuberculous mycobacterium tuberculosis and respiratory failure.It was further reported the patient deceased, however the attending physicians opinion was that the patient had likely deceased due to advanced stage colon cancer.Further information has been requested regarding the reported event, including the return of the devices.

Manufacturer Narrative

(b)(4).Product background: the myopt9medium is a nasal cannula patient interface for delivery of humidified respiratory gases, including those who are receiving nasal high flow therapy (nhf).Optiflow + interfaces are designed for use with the myairvo 2 series of humidification devices.Nhf therapy and the myairvo 2 device are intended for use with spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.The myairvo 2 device should not be used for life support purposes and appropriate patient monitoring must be used at all times.The cannula consists of a lightweight delivery tube connected to a rigid plastic base and soft nasal prongs (nasal interface).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.Method: the complaint myopt9medium optiflow + adult nasal cannula and myairspiral heated breathing 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: further information about the reported incident and the medical cause of death was requested from the healthcare facility.However, the healthcare facility did not provide any of the requested information despite several attempts to request this.The healthcare facility had reported the following sequence of events: from the (b)(6) 2022 a patient had been using oxygen during the day and switched to myairvo 2 at night at home, with no problems with the myairvo 2.The patient had advanced stage colon cancer, non-tuberculous mycobacterium tuberculosis and respiratory failure.On the morning of (b)(6) 2022, it was discovered that the patient was not breathing, and it was reported that the myopt9medium optiflow+ nasal cannula was found disconnected from the myairspiral heated breathing tube when in use with the myairvo2.It was further reported the patient deceased, however the attending physician's opinion was that the patient had likely deceased due to advanced stage colon cancer.Visual inspection of the returned myopt9medium optiflow+ nasal cannula and the myairspiral heated breathing tube revealed no damage to the devices.The force required to disconnect the myopt9medium optiflow+ nasal cannula and the myairspiral heated breathing tube was measured, and this was within specification.No fault was found with either device.The lot number for either device was not provided, therefore the specific device history records (dhrs) were unable to be reviewed.However, the dhrs are reviewed for every manufactured lot as part of the final quality control checks at the completion of the assembly process.Therefore, the subject myopt9medium optiflow+ nasal cannula and myairspiral heated breathing tube would have met all specifications at the time of release.Conclusion: we are unable to determine what caused the reported event, as no fault was found with either device.In addition, the device set up had been in use overnight, for a period of 22 days without incident.Fisher and paykel healthcare's manufacturing controls for the optiflow + tubing include inspections during production for visual defects 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.The user instructions which accompany the 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 - "failure to use the set-up described above can compromise performance and affect patient safety".

Event Description

A distributor in japan reported on the morning of (b)(6) 2022, it was discovered that the patient was not breathing and it was reported that the myopt9medium optiflow+ nasal cannula was found disconnected from the myairspiral heated breathing tube when in use with the myairvo2.From the (b)(6) 2022 the patient had been using oxygen during the day and switched to myairvo 2 at night at home, with no problems with the myairvo 2.The patient had advanced stage colon cancer, non-tuberculous mycobacterium tuberculosis and respiratory failure.It was further reported the patient deceased, however the attending physicians opinion was that the patient had likely deceased due to advanced stage colon cancer.Further information about the reported incident and the medical cause of death was requested from the healthcare facility.However, the healthcare facility did not provide any of the requested information despite several attempts to request this.

• 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 ; 9494534000
• MDR Report Key: 15080778
• MDR Text Key: 297231579
• Report Number: 9611451-2022-00640
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K162553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MYOPT9MEDIUM
• Device Catalogue Number: MYOPT9MEDIUM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/23/2022
• Initial Date FDA Received: 07/21/2022
• Supplement Dates Manufacturer Received: 08/28/2022
• Supplement Dates FDA Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 73 YR