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 Date 11/17/2022

Event Type  malfunction  

Event Description

A healthcare facility in edmonton reported, via a fisher and paykel healthcare field representative, that the tubing of an opt944 + adult nasal cannula was found torn during a patient turn.The patient's oxygen saturation did not drop below 91% spo2.The subject cannula was then replaced and there were no further reported patient consequences for the patient.

Manufacturer Narrative

Fisher & paykel healthcare is currently in the process of completing our investigation.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 gases, including those who are receiving nasal high flow therapy.Optiflow + interfaces are designed for use with the aivo 2 series of humidification 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 gases nhf therapy should noit be used for life support purposes.And appropriate monitoring must be used at all times.

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.Method: the complaint opt944 optiflow + adult nasal cannula was not returned to fisher & paykel healthcare (f&p) for evaluation and additional information such as the lot number could not be provided, as the healthcare facility had discarded the device and the packaging.Our investigation is based on the information provided by the customer, previous investigations of similar complaints, and our knowledge of the product.Results: the healthcare facility has stated that the opt944 optiflow + adult nasal cannula was found torn during a patient turn and the patient's oxygen saturation level did not drop below 91%.Further information requested from the healthcare facility confirmed that the tubing of the subject device was caught between the patient and bed rail and when the patient rolled onto their back, the tubing broke.Conclusion: without the return of the subject device for evaluation, our investigation was unable to determine the exact cause of 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 during a patient turn, while being caught between the patient and bed rail.F&p's manufacturing controls for the optiflow+ adult nasal cannula tubing include inspections during production for visual defects including cracks, tears, moulding defects, contamination, inclusions, discoloration and stretching or deformation.Any product that fails the visual inspection is rejected.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 warn: - "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." - "do not crush or stretch tube, to prevent loss of therapy." - "failure to use the set-up described above can compromise performance and affect patient safety.".

Event Description

A healthcare facility in edmonton reported, via a fisher and paykel healthcare field representative, that the tubing of an opt944 + adult nasal cannula was found torn during a patient turn.The healthcare facility further reported that the tubing of the subject device had been caught between the patient and bed rail and when the patient rolled onto their back, the tubing broke.The patient's oxygen saturation did not drop below 91% spo2.The subject cannula was then replaced and there were no further reported patient consequences for the patient.

• Brand Name: OPTIFLOW + ADULT NASAL CANNULA
• Type of Device: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, ; NZ
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland
• Manufacturer Contact: faranak gomarooni ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534002
• MDR Report Key: 16040333
• MDR Text Key: 306086478
• Report Number: 9611451-2022-01239
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): Y
• Reporter Country Code: CA
• PMA/PMN Number: K162553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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