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

Model Number OPT944

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Low Oxygen Saturation (2477)

Event Type  malfunction  

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 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.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.

Event Description

A healthcare facility in netherlands reported via a fisher and paykel healthcare (f&p) field representative that the tubing of an opt944 optiflow + adult nasal cannula was found damaged.The healthcare facility reported the following sequence of events: after a patient desaturated, the tubing of an opt944 optiflow + adult nasal cannula was found damaged.The damaged cannula was then replaced, and the healthcare facility further reported that there was no harm to the patient.

Event Description

A healthcare facility in netherlands reported via a fisher and paykel healthcare (f&p) field representative that the tubing of an opt944 optiflow + adult nasal cannula was found damaged.The healthcare facility reported the following sequence of events: after a restless patient desaturated several times with short durations, the tubing of an opt944 optiflow + adult nasal cannula was found damaged.The damaged cannula was then replaced, and the healthcare facility further reported that there was no harm to the patient.

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 and is also compatible with the fisher & paykel healthcare (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.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 complaint opt944 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 customer, previous investigations of similar complaints, and our knowledge of the product.Results: visual inspection of the opt944 optiflow + adult nasal cannula revealed that the tubing was torn next to the 3-way connector and detached from the manifold.It was also observed that several areas of the tubing were found stretched.Conclusion: our investigation was unable to determine the exact cause of the observed damage to the opt944 optiflow + adult nasal cannula.Based on our knowledge of the product, the observation of tubing being stretched, and the healthcare facility reporting that the patient was restless, the tubing was likely subjected to excessive force during use.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 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 head strap clip and the tubing clip are appropriately attached.The user instructions also state: - "do not crush or stretch tube, to prevent loss of therapy.".- "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.".- "appropriate patient monitoring must be used at all times.Failure to monitor the patient may result in loss of therapy, serious injury or death.".- "failure to use the set-up described above can compromise performance and affect patient safety.

• 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 ; 9494534000
• MDR Report Key: 16424900
• MDR Text Key: 310169105
• Report Number: 9611451-2023-00138
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K162553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2023
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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