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

Model Number OPT944

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Low Oxygen Saturation (2477)

Event Date 03/26/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 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 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 reported that the tubing of an opt944 optiflow + adult nasal cannula was found damaged during use.It was also reported that the patient desaturated to 92% spo2 at the time of the reported event and that once the subject device was replaced the patient's spo2 recovered to 96%.There were no further patient consequences reported.

Manufacturer Narrative

(b)(4).Corrected data: g1.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.Method: the complaint device was not returned for investigation.Photos of the reported damage were also requested by f&p, however none were provided.Our investigation is based on the information provided by the healthcare facility, previous investigations of similar complaints, and our knowledge of the product.Results: the healthcare facility reported that a opt944 optiflow + adult nasal cannula was found damaged during patient use.It was also reported by the healthcare facility that the subject device had been in use for around 30 hours and that the patient had been trying to adjust the device themselves and that it was possible the tubing may have been pulled.The healthcare facility reported that the patient desaturated to 92% spo2 at the time of the reported event and that once the subject device was replaced the patient recovered to 96% spo2.Conclusion: without the return of the subject device or photos of the reported damage we are unable to confirm the cause of the reported event.Based on our knowledge of the product and the healthcare facility's report that the patient has been trying to adjust the device themselves and that it was possible the tubing may have been pulled, it is likely that the reported damage would have been caused by the tubing being subjected to excessive force.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 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."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 healthcare facility reported that the tubing of an opt944 optiflow + adult nasal cannula was found damaged during use.It was also reported that the patient desaturated to 92% spo2 at the time of the reported event and that once the subject device was replaced the patient's spo2 recovered to 96%.There were no further patient consequences reported.

• 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: diego vargas banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494341005
• MDR Report Key: 19168860
• MDR Text Key: 341589873
• Report Number: 9611451-2024-00311
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012429117
• UDI-Public: (01)09420012429117(10)2102167019(11)220509
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K162553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/30/2024

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: 2102167019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/30/2024
• Initial Date FDA Received: 04/23/2024
• Supplement Dates Manufacturer Received: 05/07/2024
• Supplement Dates FDA Received: 05/27/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/09/2022
• 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 900PT561 HEATED BREATHING TUBE AND CHAMBER KIT; F&P 900PT561 HEATED BREATHING TUBE AND CHAMBER KIT; F&P PT101 AIRVO 2 HUMIDIFIER; F&P PT101 AIRVO 2 HUMIDIFIER
• Patient Age: 82 YR
• Patient Sex: Male