MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD OPTIFLOW 3S NASAL CANNULA

Model Number NOT PROVIDED

Device Problems Unintended Movement (3026); Insufficient Information (3190)

Patient Problem Low Oxygen Saturation (2477)

Event Date 01/24/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device details including the specfic model number of the subject opt104x optiflow 3s nasal cannula was not provided.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.The opt104x optiflow 3s nasal cannula is a nasal cannula patient interface for delivery of humidified respiratory gases, including those who are receiving nasal high flow therapy (nhf).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 optiflow 3s nasal cannula features side swapping capability, allowing the tubing to be positioned on either side of the patient.The interface is held in place by a head strap and features a cannula tube clip which works in tandem with the blue tubing clip (attaches to the patient's clothing/bedding) to support the weight of the circuit and prevent the cannula being dislodged.Optiflow 3s interfaces are designed for use with the airvo series humidifiers and are also compatible with the f&p mr850 and 950 humidification system devices.Optiflow 3s interfaces are intended for use with spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.Optiflow 3s interfaces are not intended for life support and appropriate patient monitoring must be used at all times.

Event Description

A healthcare facility in california reported via a fisher and paykel healthcare (f&p) field representative that an opt104x optilfow 3s nasal cannula was found removed from the patient during use and that the patient desaturated into the 80% range of spo2.The healthcare facility reported that the patient was provided with a non-rebreather mask in addition to the optiflow 3s nasal cannula and that the patient saturation recovered to 100% spo2.No further patient consequence was reported.The healthcare facility reported that there was no damage to the optiflow 3s nasal cannula.The healthcare facility was not able to specify how the subject cannula was removed from the patient, it was reported that the complaint cannula had either disconnected from the circuit, that the tubing of the cannula had disconnected from the patient interface, or that the entire cannula and circuit had fallen off the patient.It was also reported that the patient had been moving around a lot which may have caused the cannula to fall off.

Event Description

A healthcare facility in california reported via a fisher and paykel healthcare (f&p) field representative that an optilfow 3s nasal cannula was found removed from the patient during use and that the patient desaturated into the 80% range of spo2.The healthcare facility reported that the patient was provided with a non-rebreather mask in addition to the optiflow 3s nasal cannula and that the patient saturation recovered to 100% spo2.No further patient consequence was reported.The healthcare facility reported that there was no damage to the optiflow 3s nasal cannula.The healthcare facility was not able to specify how the subject cannula was removed from the patient, it was reported that the complaint cannula had either disconnected from the circuit, that the tubing of the cannula had disconnected from the patient interface, or that the entire cannula and circuit had fallen off the patient.It was also reported that the patient had been moving around a lot which may have caused the cannula to fall off.

Manufacturer Narrative

(b)(4).The device details including the model number and lot number of the subject optiflow 3s nasal cannula was not provided.Product background: the optiflow 3s nasal cannula is a nasal cannula patient interface for delivery of humidified respiratory gases, including those who are receiving nasal high flow therapy (nhf).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 optiflow 3s nasal cannula features side swapping capability, allowing the tubing to be positioned on either side of the patient.The interface is held in place by a head strap and features a cannula tube clip which works in tandem with the blue tubing clip (attaches to the patient's clothing/bedding) to support the weight of the circuit and prevent the cannula being dislodged.Optiflow 3s interfaces are designed for use with the airvo series humidifiers and are also compatible with the fisher & paykel (f&p) mr850 and 950 humidification system devices.Optiflow 3s interfaces are intended for use with spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.Optiflow 3s interfaces are not intended for life support and appropriate patient monitoring must be used at all times.Method: the complaint device was not returned to f&p for evaluation.A f&p field representative visited the hospital to provide in-service training related to this event.Our investigation is based on the information provided by healthcare facility, the information provided by the f&p field representative and our knowledge of the product.Results: the healthcare facility was not able to specify how the subject cannula was removed from the patient, it was reported that the complaint cannula had either disconnected from the circuit, that the tubing of the cannula had disconnected from the patient interface, or that the entire cannula and circuit had fallen off the patient.It was also reported that the patient had been moving around a lot which may have caused the cannula to fall off.The healthcare facility also reported that there was no damage to the optiflow 3s nasal cannula.Conclusion: as the healthcare facility was unable to confirm the exact issue that occurred with the subject cannula we are unable to determine the cause of the reported event.There was no reported damage to the subject device.A f&p field representative provided in-service training at the healthcare facility following the reported event.The user instructions which accompany the optiflow 3s nasal cannula show in pictorial format the correct placement and fitting of the cannula, including ensuring the tubing connection is properly inserted and the canula tube clip is appropriately attached.The user instructions also state: "ensure tubing connection is properly inserted." "reconnect cannula tube clip to cannula before use." failure to properly insert the tubing connection may result in loss of therapy." "failure to follow the fitting instructions 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." "do not crush or stretch tube, to prevent loss of therapy.".

• Brand Name: OPTIFLOW 3S NASAL CANNULA
• Type of Device: NASAL CANNULA
• 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: omid taheri ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 8007923912
• MDR Report Key: 18763951
• MDR Text Key: 336864099
• Report Number: 9611451-2024-00147
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191818
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/25/2024

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: NOT PROVIDED
• Device Catalogue Number: OPT104X
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/25/2024
• Initial Date FDA Received: 02/22/2024
• Supplement Dates Manufacturer Received: 03/21/2024
• Supplement Dates FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: No
• 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 PT301 AIRVO 3 HUMIDIFIER; F&P PT301 AIRVO 3 HUMIDIFIER
• Patient Age: 69 YR