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

Model Number	OPT946
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare facility in texas reported via a fisher & paykel healthcare (f&p) field representative that an opt946 optiflow + adult nasal cannula was found to have a loose connection with the heated breathing tube as part of the 900pt561 heated breathing tube during device set up.The cannula was replaced.It was further reported by the healthcare facility that the cannula was manufactured in 2015.There was no patient consequence as the event occured during device set up while the patient remained on niv therapy.
Additional Manufacturer Narrative
(b)(4).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.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.Nhf therapy and the airvo 2 device are intended for use with spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.The airvo 2 device 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.
Additional 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 (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.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 opt946 optiflow + adult nasal cannula was not returned to f&p for evaluation.Our investigation is based on the information and photograph provided by the customer, previous investigations of similar complaints, and our knowledge of the product.Results: the customer reported that the cannula would not properly connect with the heated breathing tube as part of a 900pt561 heated breathing tube and chamber kit.The customer also reported that the cannula was manufactured in 2015.Visual inspection of the provided photograph revealed the device had an old connector.Conclusion: the connector on the optiflow + adult nasal cannulas was updated in 2016.A product update was released at the time, informing customers that the optiflow + adult nasal cannulas would have a new connector from the date of manufacture: 18 july 2016, onwards.The 900pt561 heated breathing tube, which was released in 2019, would not have been able to connect with the subject cannula.
Event or Problem Description
A healthcare facility in texas reported via a fisher & paykel healthcare (f&p) field representative that an opt946 optiflow + adult nasal cannula had an insufficient connection with the heated breathing tube as part of the 900pt561 heated breathing tube and chamber kit during device set up.The cannula was replaced.It was further reported by the healthcare facility that the cannula was manufactured in 2015.There was no patient consequence as the event occured during device set up while the patient remained on niv therapy.

• Brand Name: OPTIFLOW + ADULT NASAL CANNULA
• Common Device Name: 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: 15343393
• Report Number: 9611451-2022-00791
• Device Sequence Number: 14682967
• Product Code: BTT
• UDI-Device Identifier: 09420012429155
• UDI-Public: (01)09420012429155(10)2100010224(11)151202
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K162553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2022

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
• Operator of Device: Health Professional
• Device Model Number: OPT946
• Device Catalogue Number: OPT946
• Device Lot Number: 2100010224
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2022
• Supplement Date Received by Manufacturer: 10/26/2022
• Initial Report FDA Received Date: 09/01/2022
• Supplement Report FDA Received Date: 11/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 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: 80 YR
• Patient Sex: Male