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

Model Number OPT944

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Low Oxygen Saturation (2477)

Event Date 04/26/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Fisher & paykel healthcare (f&p) is currently in the process of completing our investigation.We will provide a follow up report upon completion of our investigation.Product background: 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).Optiflow + interfaces are designed for use with the airvo 2 series of humidification devices.Nhf therapy and the airvo 2 device are 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.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.

Event Description

A healthcare facility in brazil reported via a fisher & paykel healthcare (f&p) field representative that that the tubing of an opt944 optiflow + adult nasal cannula was found detached from the 3-way connector during use.It was reported that the patient desaturated to 72% spo2.The patient was placed on a non-rebreather mask whilst the subject cannula was replaced.Upon replacement of the cannula, the patient's condition stablised.No further patient consequences were reported.

Manufacturer Narrative

(b)(4).Product background: 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).Optiflow + interfaces are designed for use with the airvo 2 series of humidification devices.Nhf therapy and the airvo 2 device are 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.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.Method: the subject opt944 optiflow + adult nasal cannula was returned to fisher & paykel healthcare (f&p) in new zealand for investigation, where it was visually inspected.An investigation was carried out by f&p which was based on the information provided by the healthcare facility the evaluation of the subject cannula, and our knowledge of the product.Results: the healthcare facility reported that the tubing of an opt944 optiflow + adult nasal cannula was found detached from the 3-way connector.The patient desaturated to 72% spo2.The patient was placed on a non-rebreather mask and the subject cannula was replaced.Upon replacement of the cannula, the patient's condition stablised.Visual inspection of the returned cannula confirmed that the tubing was detached from the 3-way connector.The tubing was also observed to be stretched at the 3-way connector end.Conclusion: we are unable to determine the cause of the reported event.However, based on our knowledge of the product and our observation that the tubing was stretched at the 3-way connector end, the reported event was likely caused by the cannula being subjected to excessive force during use.Manufacturing controls for the opt944 optiflow + adult nasal cannula include inspections during production for visual defects including cracks, tears, inclusions, discoloration and stretching or deformation.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." "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." "appropriate patient monitoring must be used at all times.Failure to monitor the patient may result in loss of therapy, serious injury or death.".

Event Description

A healthcare facility in brazil reported via a fisher & paykel healthcare (f&p) field representative that that the tubing of an opt944 optiflow + adult nasal cannula was found detached from the 3-way connector during use.It was reported that the patient desaturated to 72% spo2.The patient was placed on a non-rebreather mask whilst the subject cannula was replaced.Upon replacement of the cannula, the patient's condition stablised.No further patient consequences were reported.

• 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: 14629210
• MDR Text Key: 294950781
• Report Number: 9611451-2022-00524
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012429117
• UDI-Public: (01)09420012429117(10)2101569767(11)210325
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/09/2022

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: OPT944
• Device Catalogue Number: OPT944
• Device Lot Number: 2101569767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2022
• Initial Date FDA Received: 06/07/2022
• Supplement Dates Manufacturer Received: 06/12/2022
• Supplement Dates FDA Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2021
• 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 PT101 AIRVO 2 HUMIDIFIER; F&P PT101 AIRVO 2 HUMIDIFIER