MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD FISHER & PAYKEL HEALTHCARE; NASAL CANNULA

Model Number	OPT946
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Pneumonia (2011)
Date of Event	11/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare facility in the united kingdom reported that on 09 november 2023 the opt946 optiflow + adult nasal cannula tube had disconnected from the nasal prongs during patient use.On 12 december 2023, the healthcare facility further reported the following sequence of events.On 09 november 2023, the nurse observed the opt946 optiflow + adult nasal cannula prongs to be functioning as intended.At early hours of the morning, the nurse observed the patient to have unusual breathing, furthermore a doctor observed the patient to have cyanosis and agonal breathing.It was reported that the opt946 optiflow + adult nasal cannula tube had disconnected from the nasal prongs and was reconnected immediately.It was further reported by the healthcare facility that the patient passed away, and the medical cause of death was pneumonia.
Additional 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 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).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.
Event or Problem Description
A healthcare facility in the united kingdom reported that on (b)(6) 2023 the opt946 optiflow + adult nasal cannula tube had disconnected from the nasal prongs during patient use.On (b)(6) 2023, the healthcare facility further reported the following sequence of events.On (b)(6) 2023, the nurse observed the opt946 optiflow + adult nasal cannula prongs to be functioning as intended.At early hours of the morning, the nurse observed the patient to have unusual breathing, furthermore a doctor observed the patient to have cyanosis and agonal breathing.It was reported that the opt946 optiflow + adult nasal cannula tube had disconnected from the nasal prongs and was reconnected immediately.It was further reported by the healthcare facility that the patient passed away, and the medical cause of death was pneumonia.
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).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 opt946 optiflow + adult nasal cannula was not returned to f&p for evaluation, as it was reported to be destroyed by the healthcare facility.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 stated that the tubing of the subject opt946 optiflow + adult nasal cannula became disconnected from the nasal prongs during patient use.On 12 december 2023, the healthcare facility further reported the following sequence of events.On 09 november 2023, the nurse observed the opt946 optiflow + adult nasal cannula prongs to be functioning as intended.At early hours of the morning, the nurse observed the patient to have unusual breathing, furthermore a doctor observed the patient to have cyanosis and agonal breathing.It was reported that the opt946 optiflow + adult nasal cannula tube had disconnected from the nasal prongs and was reconnected immediately.It was further reported by the healthcare facility that the patient passed away, and the medical cause of death was pneumonia.Conclusion: f&p made attempts to retrieve the device and device photgraphs, however it was reported the device was destroyed by the healthcare facility.Without photographs of the reported malfunction or the return of the subject device, our investigation was unable to determine the exact cause of the reported event.Manufacturing controls include inspections during production for visual defects to the optiflow + tubing and the swivel, including cracks, tears, moulding defects, contamination, inclusions, discoloration and stretching or deformation.The optiflow + tubing is also inspected for any assembly defects, including confirmation the swivel and 3-way connector are connected with the correct engagement.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: - "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 or Problem Description
A healthcare facility in the united kingdom reported that on (b)(6) 2023 the opt946 optiflow + adult nasal cannula tube had disconnected from the nasal prongs during patient use.On (b)(6) 2023, the healthcare facility further reported the following sequence of events.On (b)(6) 2023, the nurse observed the opt946 optiflow + adult nasal cannula prongs to be functioning as intended.At early hours of the morning, the nurse observed the patient to have unusual breathing, furthermore a doctor observed the patient to have cyanosis and agonal breathing.It was reported that the opt946 optiflow + adult nasal cannula tube had disconnected from the nasal prongs and was reconnected immediately.It was further reported by the healthcare facility that the patient passed away, and the medical cause of death was pneumonia.
Additional Manufacturer Narrative
(b)(4).Udi related data quality updates only.Corrections to reflect gudid: section d1: brand name updated to fisher & paykel healthcare.Section g1: contact person updated to mr.(b)(6).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).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 opt946 optiflow + adult nasal cannula was not returned to f&p for evaluation, as it was reported to be destroyed by the healthcare facility.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 stated that the tubing of the subject opt946 optiflow + adult nasal cannula became disconnected from the nasal prongs during patient use.On 12 december 2023, the healthcare facility further reported the following sequence of events.On (b)(6) 2023, the nurse observed the opt946 optiflow + adult nasal cannula prongs to be functioning as intended.At early hours of the morning, the nurse observed the patient to have unusual breathing, furthermore a doctor observed the patient to have cyanosis and agonal breathing.It was reported that the opt946 optiflow + adult nasal cannula tube had disconnected from the nasal prongs and was reconnected immediately.It was further reported by the healthcare facility that the patient passed away, and the medical cause of death was pneumonia.Conclusion: f&p made attempts to retrieve the device and device photgraphs, however it was reported the device was destroyed by the healthcare facility.Without photographs of the reported malfunction or the return of the subject device, our investigation was unable to determine the exact cause of the reported event.Manufacturing controls include inspections during production for visual defects to the optiflow + tubing and the swivel, including cracks, tears, moulding defects, contamination, inclusions, discoloration and stretching or deformation.The optiflow + tubing is also inspected for any assembly defects, including confirmation the swivel and 3-way connector are connected with the correct engagement.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: - "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: FISHER & PAYKEL HEALTHCARE
• Common Device Name: 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: 18367098
• Report Number: 9611451-2023-01186
• Device Sequence Number: 7743092
• Product Code: BTT
• UDI-Device Identifier: 09420012429155
• UDI-Public: (01)09420012429155(10)2100322756(11)170928
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K162553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/14/2023

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
• Operator of Device: Health Professional
• Device Model Number: OPT946
• Device Catalogue Number: OPT946
• Device Lot Number: 2100322756
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2023
• Supplement Date Received by Manufacturer: 02/22/2024; 02/22/2024
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 02/28/2024; 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/28/2017
• 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 PT101 AIRVO 2 HUMIDIFIER; F&P PT101 AIRVO 2 HUMIDIFIER.; F&P PT101 AIRVO 2 HUMIDIFIER.
• Outcome Attributed to Adverse Event: Other; Death
• Patient Age: 72 YR
• Patient Sex: Unknown