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

Model Number OPT944

Device Problems Stretched (1601); Detachment of Device or Device Component (2907)

Patient Problem Low Oxygen Saturation (2477)

Event Date 04/18/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.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 and may also be compatible with the fisher and paykel mr850 and 950 humidification system devices.Nhf therapy is intended for use with spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases nhf therapy 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 distributor reported on behalf of a healthcare facility in japan via a fisher and paykel healthcare (f&p) field representative that the tubing of an opt944 optiflow + adult nasal cannula had detached from the 3-way connector.This occurred when the patient was turning onto their side.The patient notified the clinical staff immediately and the cannula was replaced.During this time, the patient's spo2 dropped from 98% to 93% spo2; however, returned to 99% upon replacement of the cannula.There were no further patient consequences reported.Additional information provided by the healthcare facility confirmed that the headstrap clip and the tubing clip of the cannula were not being used at the time of the reported event.

Manufacturer Narrative

(b)(4).Product background: the (b)(6) 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).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 eatures 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 and is also compatible with the f&p mr850 and 950 humidification system devices.Nhf therapy is intended for use with spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases nhf therapy should not be used for life support purposes, and appropriate patient monitoring must be used at all times.Method: the complaint (b)(4) optiflow + adult nasal cannula was received at f&p in new zealand for investigation, where it was visually inspected.Our investigation is based on our evaluation of the subject device, information provided by the healthcare facility, previous investigations of similar complaints, and our knowledge of the product.Results: visual inspection of the (b)(4) optiflow + adult nasal cannula revealed that the tubing of the (b)(4) optiflow + adult nasal cannula was detached from the 3-way connector.The nasal prongs were found partially disconnected from the manifold.The tubing was found stretched at the manifold and the connector end.During this time, the patient's spo2 dropped from 98% to 93% spo2; however, returned to 99% upon replacement of the cannula.There were no further patient consequences reported.Additional information provided by the healthcare facility confirmed that the headstrap clip and the tubing clip of the cannula were not being used at the time of the reported event.The healthcare facility also reported that the tube was tied loosely on the side of the bed.Conclusion: while our investigation is unable to determine the exact cause of the observed damage to the (b)(6) optiflow + adult nasal cannula, based on our knowledge of the product the damage to the tubing, disconnection of the nasal prongs, and detachment from the 3-way connector was likely due to excessive force on the tube during use.The excessive force on the tube would likely have occurred from the tubing being tied to the side of the bed and while the patient was turning on their side.The healthcare facility also reported that the subject (b)(6) optiflow + adult nasal cannula was used without the white headgear clip and blue clothing/bedding clip.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.The user instructions which accompany the optiflow + interfaces for japan set out how the cannula should be placed and fitted, including the use of the head strap clip.The user instructions for japan also state the following: - "do not pull, squeeze, crush, or strongly pinch the breathing tube until the tube is deformed".- "it is recommended to use appropriate patient monitoring with this product ".- "fit the prongs to the patient's nose and secure it to the patient with the head strap.Make sure that the clip is secured to the head strap".- "use the clip to secure the tube to the prongs." - "it is recommended to use appropriate patient monitoring with this product ".- "make sure that an air flow is coming out of the prongs when using the product in the patient".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.The subject (b)(6) optiflow + adult nasal cannula would have met the required specifications.

Event Description

A distributor reported on behalf of a healthcare facility in japan via a fisher and paykel healthcare (f&p) field representative that the tubing of an (b)(6) optiflow + adult nasal cannula had detached from the 3-way connector.This occurred when the patient was turning onto their side.The patient notified the clinical staff immediately and the cannula was replaced.During this time, the patient's spo2 dropped from 98% to 93% spo2; however, returned to 99% upon replacement of the cannula.There were no further patient consequences reported.Additional information provided by the healthcare facility confirmed that the headstrap clip and the tubing clip of the cannula were not being used at the time of the reported event.The healthcare facility also reported that the tube was tied loosely to the side of the bed.

• 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: omid taheri ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 8007923912
• MDR Report Key: 17008319
• MDR Text Key: 316887782
• Report Number: 9611451-2023-00474
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012429117
• UDI-Public: (01)09420012429117(10)2101941869(11)211208
• 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,User Facility,Company Representative,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/28/2023

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: 2101941869
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2023
• Initial Date FDA Received: 05/25/2023
• Supplement Dates Manufacturer Received: 07/09/2023
• Supplement Dates FDA Received: 08/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2021
• 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