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

Model Number NOT PROVIDED

Device Problem Material Split, Cut or Torn (4008)

Patient Problems Cardiac Arrest (1762); Hypoxia (1918); Insufficient Information (4580)

Event Date 12/27/2023

Event Type  Death  

Event Description

A healthcare facility in united states reported via a fisher and paykel healthcare (f&p) field representative on 3 january 2024 that the tubing of an opt944 optiflow + adult nasal cannula broke during patient use.It was reported that the patient had covid-19 and had become hypoxic.The patient was receiving therapy via an opt944 optiflow + adult nasal cannula.It was reported that the hospital staff were proning the patient and the complaint device broke and there was no backup cannula available.It was reported that the patient went into cardiac arrest and later deceased.F&p has requested further information on the event and the complaint device for evaluation.F&p is currently in the process of completing our investigation.F&p will provide a follow up report upon completion of our investigation.

Manufacturer Narrative

(b)(4).Fisher and paykel healthcare (f&p) has requested further information on the event and the complaint device for evaluation.F&p is currently in the process of completing our investigation.F&p 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).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.Optiflow + interfaces are designed for use with the airvo series humidifiers and are also compatible with the fisher & paykel healthcare (f&p) mr850 and 950 humidification system devices.Optiflow + interfaces are intended for use with spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.Optiflow + interfaces are not intended for life support and appropriate patient monitoring must be used at all times.

Event Description

A healthcare facility in united states reported via a fisher and paykel healthcare (f&p) field representative on 3 january 2024 that the tubing of a nasal cannula broke during patient use.The model number of the nasal cannula was not provided, and it is unknown whether the nasal cannula used was a f&p device.It was reported that the patient had covid-19 and was receiving therapy via a nasal cannula.It was reported that the hospital staff were pronging the patient and the nasal cannula broke and there was no backup cannula available.It was reported that the patient became hypoxic, went into cardiac arrest and later deceased.F&p has made multiple attempts to obtain further information regarding the sequence of events, the therapy being provided, the details of the nasal cannula, and further patient information, however no information was provided by the healthcare facility.

Manufacturer Narrative

(b)(4), corrected data.The healthcare facility reported that the patient had covid-19 and was receiving therapy via a nasal cannula.It was reported that the hospital staff were pronging the patient and the nasal cannula broke and there was no backup cannula available.It was reported that the patient became hypoxic, went into cardiac arrest and later deceased.Fisher & paykel healthcare (f&p) reported this event in the initial mdr as a opt944 optiflow + adult nasal cannula based on the knowledge that the opt944 optiflow + nasal cannula is a commonly used nasal cannula, and on the fact that this event was reported to f&p.F&p has made multiple attempts to obtain further information regarding the sequence of events, the therapy being provided, the details of the nasal cannula, and further patient information, however no information was provided by the healthcare facility.It is unknown whether the nasal cannula used was a f&p device.

• Brand Name: OPTIFLOW + ADULT 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: 18630407
• MDR Text Key: 335412595
• Report Number: 9611451-2024-00071
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NOT PROVIDED
• Device Catalogue Number: NOT PROVIDED
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2024
• 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
• Patient Outcome(s): Death
• Patient Age: 60 YR
• Patient Sex: Male