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

Model Number OPT944E

Device Problem Material Split, Cut or Torn (4008)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(6) the family member also reported damage to another opt944e optiflow + adult nasal cannula that is reported separately under mfr: 9611451-2024-00166, f&p ref:(b)(6).It was reported that the subject device was discarded.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.Product background: the opt944e 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.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 family member reported on behalf of a homecare patient in the united kingdom via a fisher & paykel healthcare (f&p) field representative that the tubing of an opt944e optiflow + adult nasal cannula was found damaged with a small hole during use.There were no reported patient consequences.It was also reported by the family member that the patient had been using the interface with a pt100 myairvo 2 humidifier and had two separate device setups that they had been alternating use of to allow for cleaning.It was reported that the interfaces were changed every 8 weeks.

Manufacturer Narrative

(b)(4).The family member also reported damage to another opt944e optiflow + adult nasal cannula that is reported separately under mfr: 9611451-2024-00166, f&p ref: (b)(4).Product background: the opt944e 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.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.Method: the complaint opt944e optiflow + adult nasal cannula was not returned to f&p for evaluation as the customer reported that they had discarded the subject device.Our investigation is based on the information provided by the customer, previous investigations of similar complaints, and our knowledge of the product.Results: the customer has stated that the opt944e optiflow + adult nasal cannula was damaged with a small hole in the tubing.The subject interface was used in a homecare setting with the customer alternating use between two device setups to allow for cleaning.While the duration of use of the subject cannula was not provided, it was reported by the customer that the interfaces were replaced every 8 weeks.There were no patient consequences reported by the customer.Conclusion: without the return or photos of the subject device our investigation is unable to confirm the reported damage.Based on our knowledge of the product, the reported damage is likely to have been caused by the tubing being subjected to excessive force.The customer also reported that the interfaces were replaced every 8 weeks.The user instructions which accompany the opt944e optiflow + adult nasal cannula state that "this product is intended to be used for a maximum of 30 days providing daily and weekly cleaning instructions are followed." f&p's manufacturing controls for the optiflow + tubing include inspections during production for visual defects including cracks, tears, moulding defects, contamination, inclusions, discoloration and stretching or deformation.The subject opt944e optiflow + adult nasal cannula would have met the required specifications.The user instructions which accompany the opt944e optiflow + adult nasal cannula also 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 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.".

Event Description

A family member reported on behalf of a homecare patient in the united kingdom via a fisher & paykel healthcare (f&p) field representative that the tubing of an opt944e optiflow + adult nasal cannula was found damaged with a small hole during use.There were no reported patient consequences.It was also reported by the family member that the patient had been using the interface with a pt100 myairvo 2 humidifier and had two separate device setups that they had been alternating use of to allow for cleaning.It was reported that the interfaces were changed every 8 weeks.

• 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: 18813510
• MDR Text Key: 336989095
• Report Number: 9611451-2024-00167
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K162553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: OPT944E
• Device Catalogue Number: OPT944E
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/10/2024
• 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 PT100 MYAIRVO 2 HUMIDIFIER; F&P PT100 MYAIRVO 2 HUMIDIFIER