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

Model Number NOT PROVIDED

Device Problem Disconnection (1171)

Patient Problem Low Oxygen Saturation (2477)

Event Type  Injury  

Manufacturer Narrative

(b)(6).Product background: the 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 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 optiflow + adult nasal cannula and 900pt561 heated breating tube were not returned to fisher & paykel healthcare (f&p) for evaluation.The health care facility has stated they were both discarded.Our investigation is based on the information provided by the customer, previous investigations of similar complaints, and our knowledge of the product.Results: the customer has stated that the optiflow+ cannula had disconnected from the 900pt561 heated breathing tube.The cannula was reconnected to the heated breathing tube and was confirmed to be intact.Conclusion: our investigation was unable to determine the cause of the reported disconnection.Based on our knowledge of the product and the information provided by the customer that the patient was pulling the cannula and circuit frequently, the reported disconnection is likely to have been caused by the tubing being subjected to excessive force during use.The healthcare facility reported that the medical cause of death was sepsis.Fisher and paykel healthcare's manufacturing controls for the optiflow + adult nasal cannula 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 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.

Event Description

A healthcare facility in california reported via a fisher and paykel healthcare (f&p) field representative, that the staff were alerted by a monitor in the nurse's station to a septic patient in icu who had desaturated to 70% spo2 and had bradycardia.While staff were checking the patient, it was discovered an optiflow + adult nasal cannula had disconnected from the 900pt561 heated breathing tube.The cannula was immediately reconnected and was confirmed to be intact.Upon assessment, the patient's cardiac rhythm was in asystole, and they deceased 15 minutes later.It was reported that the patient had dnr and dni orders.The healthcare facility stated the medical cause of death was sepsis.The healthcare facility further reported that the patient had been constantly trying to remove the cannula from her nose and had desaturated after these instances.The patient was also observed pulling on the circuit.Fisher and paykel requested the following information from the healthcare facility; the model number, the lot number, and the return of the optiflow+ cannula and 900pt561 heated breathing tube, however these devices were discarded by the healthcare facility and could not be provided.

• 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: 15811846
• MDR Text Key: 303800981
• Report Number: 9611451-2022-01049
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NOT PROVIDED
• Device Catalogue Number: NOT PROVIDED
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2022
• 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: F&P 900PT561 AIRVO TUBE AND CHAMBER KIT; F&P PT101 AIRVO 2 HUMIDIFIER
• Patient Outcome(s): Other
• Patient Age: 82 YR
• Patient Sex: Female