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

Model Number OPT946

Device Problems Failure to Deliver (2338); Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)

Patient Problem Low Oxygen Saturation (2477)

Event Type  malfunction  

Event Description

A healthcare facility in finland reported, via a fisher & paykel healthcare (f&p) field representative that the tubing of an opt946 optiflow + adult nasal cannula detached from the connector during use.The patient desaturated to 58% sp02.Their blood pressure had dropped and the patient lost consciousness.The subject cannula was replaced and the patients oxygen saturation recovered.The patient was administered noradrenaline for the hypertension and the blood pressure rose and they regained consciousness.No further patient consequences were reported.

Manufacturer Narrative

(b)(4).F&p has requested the complaint opt946 optiflow + adult nasal cannula 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.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 finland reported, via a fisher & paykel healthcare (f&p) field representative that the tubing of an opt946 optiflow + adult nasal cannula was broken near the connector during use.Prior to the incident, the patient had poor oxygenation and had been declining over the course of the day.The spo2 levels gradually decreased despite airvo treatment, with the patient also on many different drugs for undisclosed reasons.After the incident, the patient desaturated to 58% spo2.Their blood pressure had dropped, and the patient lost consciousness.The patient was administered noradrenaline for the hypertension, their blood pressure rose, and they regained consciousness.The subject cannula was replaced, and the patient's oxygen saturation recovered to above 80%, which was the goal of treatment for this particular patient's circumstances.No further patient consequences were reported.

Manufacturer Narrative

(b)(4).B5 narration corrected from initial report to reflect further information received from the heathcare facility.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 (nhf) therapy.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.Method: the healthcare facility stated they no longer had the complaint opt946 optiflow + adult nasal cannula, therefore it was not returned to fisher & paykel healthcare (f&p) for evaluation.An investigation was carried out by f&p which was based on the information provided by the healthcare facility and our knowledge of the product.Results: the healthcare facility reported the following sequence of events: a patient with pleural effusion with bullae found in the lungs and poor oxygenation was treated with nhf using pt101 airvo 2 and opt946 optiflow + adult nasal cannula.The patient's spo2 was gradually decreasing over the day.The patient then desaturated to spo2 of 58%.The tubing of the opt946 optiflow + adult nasal cannula was found broken near the connector.The subject cannula was replaced, and the patient's oxygen saturation recovered to above 80% spo2 in ten minutes, which was considered the optimum oxygen saturation for this patient.As the patient had lost consciousness due to their blood pressure dropping, the patient was administered noradrenaline and regained consciousness.The customer has stated that the tubing of the opt946 optiflow + adult nasal cannula was broken near the connector during use.There were no further patient consequences were reported.Conclusion: we are unable to determine the cause of the reported event.However, based on our knowledge of the product and our observation that the tubing was in use for eight days without issue, the reported event was likely caused by the cannula being subjected to excessive force during use.Manufacturing controls for the opt946 optiflow + adult nasal cannula include inspections during production for visual defects including cracks, tears, inclusions, discoloration and stretching or deformation.Any product that fails the visual inspection is disposed of.The subject opt946 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 headstrap 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.

• 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 ; 9494534000
• MDR Report Key: 14750776
• MDR Text Key: 295973707
• Report Number: 9611451-2022-00560
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012422347
• UDI-Public: (01)09420012422347(10)2100984820(11)200117
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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
• Type of Report: Initial,Followup
• Report Date: 06/08/2022

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
• Device Operator: Health Professional
• Device Model Number: OPT946
• Device Catalogue Number: OPT946
• Device Lot Number: 210572163
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/08/2022
• Initial Date FDA Received: 06/20/2022
• Supplement Dates Manufacturer Received: 09/02/2022
• Supplement Dates FDA Received: 09/19/2022
• 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: FISHER AND PAYKEL PT101 AIRVO 2 HUMIDIFER