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

Model Number OPT942

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Cardiac Arrest (1762)

Event Date 03/08/2024

Event Type  Death  

Event Description

On 27 march 2024, a healthcare facility in switzerland reported via a fisher and paykel (f&p) healthcare field representative that on 8 march 2024 the tubing of an opt944 optiflow + adult nasal cannula disconnected during patient use.The healthcare facility reported that the patient was having palliative care, subsequently had a cardiac arrest, and no resuscitative measures were taken.The healthcare facility reported that the patient subsequently deceased.F&p healthcare has requested further information on the event and the complaint device for evaluation.

Manufacturer Narrative

(b)(4).F&p healthcare has requested further information on the event and the complaint device for evaluation.F&p 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 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.

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 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: f&p requested the return of the subject device, however the subject device was not returned to f&p for evaluation.F&p's investigation is therefore based on the limited information and the photographs provided by swissmedic, previous investigations of similar complaints, and f&p's knowledge of the product.Results: a visual inspection of the photographs provided by swissmedic revealed that the tubing of the subject device was detached from the 3-way connector and the tubing was slightly stretched near the manifold connection.The film of the tubing was wrinkled.This would appear to indicate that an external force was applied to the tubing.The healthcare facility reported that the patient subsequently had a cardiac arrest, however as the patient was palliative no resuscitative measures were taken.The healthcare facility reported that the patient subsequently deceased.Conclusion: f&p's investigation was unable to determine the exact cause of the observed damage to the opt942 optiflow + adult nasal cannula.Based on f&p's knowledge of the product, the tubing was likely subjected to excessive force.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 opt942 optiflow + adult nasal cannula would have met the required specifications.The device history record (dhrs) for the lot was unable to be reviewed as the healthcare facility did not provide the lot number for the subject device.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: "this device is not intended for life support.Do not use on patients who cannot tolerate a brief interruption of therapy, to avoid serious injury or death." "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." "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." "failure to use the set-up described above can compromise performance and affect patient safety.".

Event Description

On 27 march 2024, a healthcare facility in switzerland reported via a fisher and paykel (f&p) healthcare field representative that on (b)(6) 2024 the tubing of an opt944 optiflow + adult nasal cannula disconnected during patient use.The healthcare facility reported that the patient subsequently had a cardiac arrest, however as the patient was palliative no resuscitative measures were taken.The healthcare facility reported that the patient subsequently deceased.On 4 april 2024, f&p healthcare received an email from swissmedic which included photographs of the subject device.From the photographs, it appears that the subject device is an opt942 optiflow + adult nasal cannula.This report has been updated accordingly.This also means that the original lot number provided by the healthcare facility would appear to be incorrect.The photographs provided by swissmedic on 4 april 2024 illustrate a disconnection between the opt942 optiflow + adult nasal cannula tubing and its connector to the gas flow source.

• 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: diego banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494341005
• MDR Report Key: 19169727
• MDR Text Key: 340896810
• Report Number: 9611451-2024-00297
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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?: No
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/23/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/30/2024
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Death
• Patient Age: 40 YR
• Patient Sex: Female