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

Model Number OPT942

Device Problem Material Split, Cut or Torn (4008)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Fisher & paykel healthcare (f&p) is in the process of completing our investigation.We will provide a follow up report upon completion of our investigation.Product background: the opt942 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 2 series of humidification devices and is also compatible with the 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.

Event Description

A healthcare facility in netherlands reported that the tubing of an opt942 optiflow + adult nasal cannula was found damaged during patient use.There were no reported patient consequences.

Event Description

A healthcare facility in netherlands reported that the tubing of an opt942 optiflow + adult nasal cannula was found damaged during patient use.There were no reported patient consequences.

Manufacturer Narrative

(b)(4).Product background: the opt942 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 2 series of humidification devices and is also compatible with the 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.Method: the complaint opt942 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 healthcare facility, previous investigations of similar complaints, and our knowledge of the product.Results: visual inspection of the opt942 optiflow + adult nasal cannula revealed that the tubing had damage at three sections.The tube was stretched and torn near the swivel connector, delaminated near the user end and damage was observed at the manifold.The film of the tubing was wrinkled which indicates the damage was consistent with an external force being applied to the tubing.There were no patient consequences reported by the healthcare facility.In addition, the healthcare facility reported that they had pulled on the tubing, resulting in more damage than initially reported.Conclusion: our investigation was unable to determine the cause of the observed damage to the opt942 optiflow + adult nasal cannula.Based on our knowledge of the product the tubing was likely 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 opt942 optiflow + adult nasal cannula would have met the required specifications.The user instructions which accompany the opt942 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: 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: 17882572
• MDR Text Key: 325079874
• Report Number: 9611451-2023-00923
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/07/2023

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: OPT942
• Device Catalogue Number: OPT942
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/05/2023
• Supplement Dates Manufacturer Received: 11/09/2023
• Supplement Dates FDA Received: 11/22/2023
• 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