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

Model Number OPT1046

Device Problem Disconnection (1171)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

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.The opt1046 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.This report is related to 3 other events reported by the healthcare facility: - mfr: 9611451-2024-00132, f&p ref: (b)(4).- mfr: 9611451-2024-00133, f&p ref: (b)(4).- mfr: 9611451-2024-00134, f&p ref: (b)(4).

Event Description

A healthcare facility in (b)(6) reported via a fisher and paykel healthcare (f&p) field representative that the tubing connection of an opt1046 optilfow 3s nasal cannula had disconnected from the patient interface during use.The f&p field representative observed that the healthcare facility was not using the tube clip.It was reported by the healthcare facility that the patient, who had covid-19, was having hard work breathing at the time of event.There was no further patient consequences reported.

Event Description

A healthcare facility in washington reported via a fisher and paykel healthcare (f&p) field representative that the tubing connection of an opt1046 optiflow 3s nasal cannula had disconnected from the patient interface during use.While providing in-service training the f&p field representative observed that the healthcare facility was not using the cannula tube clip.It was reported by the healthcare facility that the patient, who had covid-19, was having hard work breathing at the time of event.There were no further patient consequences reported.

Manufacturer Narrative

(b)(4).The healthcare facility reported that they had four separate occasions of the optiflow 3s nasal cannula disconnecting from the patient interface.The other three events are reported separately under the following references: mfr: 9611451-2024-00132, f&p ref: (b)(4).Mfr: 9611451-2024-00133, f&p ref: (b)(4).Mfr: 9611451-2024-00134, f&p ref: (b)(4).Product background: the opt1046 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 opt1046 optiflow 3s nasal cannula 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 and photograph provided by the healthcare facility, the information provided by the f&p field representative and our knowledge of the product.Results: visual inspection of the provided photograph revealed that the tubing connection of the opt1046 optiflow 3s nasal cannula was partially disconnected from the patient interface.There was no reported damage to the subject cannula.A f&p field representative observed that the healthcare facility was not using the cannula tube clip.Conclusion: the reported disconnection is likely to have occurred as a result of the healthcare facility not using the cannula tube clip as observed by the f&p field representative.There was no reported damage to the subject device.A f&p field representative provided in-service training at the healthcare facility.The user instructions which accompany the opt1046 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: 18744739
• MDR Text Key: 336873099
• Report Number: 9611451-2024-00025
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OPT1046
• Device Catalogue Number: OPT1046
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2024
• 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