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

Model Number OPT946

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Low Oxygen Saturation (2477)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product background: the opt946 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 canada reported, via a fisher and paykel healthcare field representative, that the tubing of two opt946 + adult nasal cannulas were found damaged after 4 hours use on a patient.The healthcare facility also reported that the patient desaturated, but there was no harm to the patient.

Manufacturer Narrative

(b)(4).Product background: the opt946 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: several attempts to request the subject device and further information from the healthcare facility were made, however no response was provided by the healthcare facility.Our investigation is thus based on the initial information and photograph provided by the healthcare facility, previous investigations of similar complaints,and our knowledge of the product.Results: visual inspection of the provided photograph revealed the tubing of the opt946 optiflow + adult nasal cannula was torn near the 3-way connector.Conclusion: our investigation was unable to determine the cause of the reported damage.Based on our knowledge of the product and previous investigations, the reported damage is likely to have been caused by the tubing being subjected to excessive force during use.Fisher and paykel healthcare'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 opt946 optiflow + adult nasal cannula would have met the required specifications.The user instructions which accompany the opt946 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: "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 canada reported, via a fisher and paykel healthcare field representative, that the tubing of two opt946 + adult nasal cannulas were found damaged after 4 hours use on a patient and the patient desaturated.The healthcare facility also reported that the damaged cannulas were replaced and there was no harm to 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, 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 ; 9494534002
• MDR Report Key: 16344877
• MDR Text Key: 309473291
• Report Number: 9611451-2023-00090
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012429155
• UDI-Public: (01)09420012429155(10)2101455155(11)210111
• Combination Product (y/n): N
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OPT946
• Device Catalogue Number: OPT946
• Device Lot Number: 2101455155
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2021
• 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