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

Model Number OPT944

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 10/09/2022

Event Type  Death  

Manufacturer Narrative

(b)(4).Fisher & paykel healthcare (f&p) has requested for the subject device to be returned for evaluation.We will provide a follow up report upon the completion of our investigation.Product background: the opt944 optiflow + adult nasal cannula is a nasal cannula patient interface for delivery of humidified respiratory gases.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.

Event Description

A healthcare facility in the united kingdom reported via a fisher & paykel healthcare (f&p) field representative that the tubing of an opt944 optiflow + adult nasal cannula was found detached from the 3-way connector during use.The staff were attending to a deteriorating patient, and they noticed the damaged opt944 optiflow + adult nasal cannula.It was reported by the healthcare facility the patient deceased after the opt944 had been removed.It is unknown if there is any causal relationship between the subject device and the patient death.Further information has been requested from the healthcare facility regarding the sequence of events and the medical cause of death.

Event Description

A healthcare facility in the united kingdom reported via a fisher & paykel healthcare (f&p) field representative that the tubing of an opt944 optiflow + adult nasal cannula was found detached from the 3-way connector during use.The staff were attending to a deteriorating patient, and they noticed the damaged opt944 optiflow + adult nasal cannula.It was reported by the healthcare facility that the patient deceased.It is unknown if there is any causal relationship between the reported event and the patient death.Multiple attempts were made to request both the return of the device and further information from the healthcare facility.However, no response was provided by the healthcare facility and the device was not returned.

Manufacturer Narrative

(b)(4).Product background: the opt944 optiflow + adult nasal cannula is a nasal cannula patient interface for delivery of humidified respiratory gases.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 subject opt944 optiflow + adult nasal cannula was not returned to fisher & paykel healthcare (f&p) for evaluation.Multiple attempts were made to request both the return of the device and further information from the healthcare facility.However, no response was provided by the healthcare facility and the device was not returned.Our investigation is therefore based on the initial information and photograph provided by the customer, and our knowledge of the product.Results: visual inspection of the provided photograph revealed the tubing of the opt944 optiflow + adult nasal cannula had detached from the 3-way connector.It is unknown if there is any causal relationship between the reported event and the patient death.Conclusion: our investigation was unable to determine the cause of the observed damage to the subject opt944 optiflow + adult nasal cannula.Based on our knowledge of the product, 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 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.The user instructions also warn: "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 the united kingdom reported via a fisher & paykel healthcare (f&p) field representative that the tubing of an opt944 optiflow + adult nasal cannula was found detached from the 3-way connector during use.The staff were attending to a deteriorating patient, and they noticed the damaged opt944 optiflow + adult nasal cannula.It was reported by the healthcare facility that the patient deceased.On 14 aug 2023, the healthcare facility provided further information.The healthcare facility reported that the patient had severe copd, chronic hypoxia, and a dnacpr order and the patient was very unwell with a saturation level of 66%.The healthcare facility also reported the following sequence of events: on 09 october 2022, at 03:45, the patient self-disconnected the opt944 optiflow + adult nasal cannula.Following the disconnection, the healthcare facility staff acted on the issue and performed a set of observations and advised the patient on the importance of keeping the nasal cannula in place.At that time, the saturation level was within an acceptable range.At 06:27, a healthcare assistant alerted the staff nurse that the patient was unresponsive and not breathing.The doctor was called and assessed the patient, who was then declared dead.It was discovered that the tubing of the opt944 optiflow + adult nasal cannula had become detached from the 3-way connector at the time of the patient's deterioration and death.Due to the dnacpr order, no resuscitation attempts were made.The healthcare facility stated the patient was unsupervised at the time of the incident.

Manufacturer Narrative

(b)(4).Product background: the opt944 optiflow + adult nasal cannula is a nasal cannula patient interface for delivery of humidified respiratory gases.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 opt944 optiflow + adult nasal cannula was not returned to f&p for evaluation.Our investigation is based on the 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 opt944 optiflow + adult nasal cannula had detached from the 3-way connector.In addition, the healthcare facility reported on (b)(6) 2023 that the patient had severe copd and chronic hypoxia while the patient was very unwell with the saturation level of 66%.It was also stated that the patient self-disconnected the opt944 optiflow + adult nasal cannula before the reported event occurred and the tubing of the subject cannula was found detached from the 3-way connector at the time of the patient's deterioration and death.The healthcare facility stated the patient was unsupervised at the time of the incident.No resuscitation attempts were made due to the dnacpr order.It is unknown if there is any causal relationship between the reported event and the patient death.Conclusion: our investigation was unable to determine the cause of the observed damage to the subject opt944 optiflow + adult nasal cannula.Based on our knowledge of the product and the information received from the healthcare facility, the damage is likely to have been caused by the tubing being subjected to excessive force during use.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 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.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: 15765528
• MDR Text Key: 303387914
• Report Number: 9611451-2022-01035
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K162553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OPT944
• Device Catalogue Number: OPT944
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 AIRVO TUBE AND CHAMBER KIT; F&P 900PT561 AIRVO TUBE AND CHAMBER KIT; F&P 900PT561 AIRVO TUBE AND CHAMBER KIT; F&P PT101 AIRVO 2 HUMIDIFIER; F&P PT101 AIRVO 2 HUMIDIFIER; F&P PT101 AIRVO 2 HUMIDIFIER
• Patient Outcome(s): Death
• Patient Age: 82 YR
• Patient Sex: Male