MAUDE Adverse Event Report: OPTIFLOW + ADULT NASAL CANNULA; BTT

Model Number OPT944

Device Problems Disconnection (1171); Detachment of Device or Device Component (2907)

Patient Problems Viral Infection (2248); Low Oxygen Saturation (2477)

Event Date 11/08/2020

Event Type  Death  

Manufacturer Narrative

(b)(4).Lot #: the healthcare facility was unsure which batch was incriminated between 2101115978 and 2101195103.The complaint opt944 optiflow adult nasal cannula is not expected to return to fisher & paykel healthcare (f&p) for evaluation.We are currently in the process of determining if our product caused or contributed to the reported event.We will provide a follow-up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that a patient desaturated to 75% spo2 when they moved positions resulting in the opt944 optiflow adult nasal cannula becoming displaced from the patient's nostrils.A healthcare professional corrected the position of the cannula and secured it to the patient using adhesive tape.The patient recovered to 95% spo2.Twenty-four hours later, it was reported that the patient desaturated to below 70% spo2 after the tubing of the optiflow adult nasal cannula became detached from the cannula connector.The patient was manually mechanically ventilated.The patient later deceased, and no further resuscitation was attempted as the patient was at end of life.It was noted that covid-19 was the medical cause of death.

Event Description

A healthcare facility in france reported via a fisher & paykel healthcare (f&p) field representative that a patient desaturated to 75% spo2 when they moved positions, resulting in the opt944 optiflow + adult nasal cannula becoming displaced from the patient's nostrils.A healthcare professional corrected the position of the cannula and the patient was returned to a seated position at which point they recovered to 95% spo2.Twenty-four hours later, it was reported that the patient desaturated to below 70% spo2 after the tubing of the optiflow + adult nasal cannula became detached from the cannula connector.Adhesive tape was used to secure the cannula tubing to the cannula connector.The patient was manually mechanically ventilated.The patient later deceased, and no further resuscitation was attempted as the patient was at end of life.It was noted that covid-19 was the medical cause of death.

Manufacturer Narrative

(b)(4).D4 lot # and h4 device manufacture date: the healthcare facility was unsure which batch was incriminated between 2101115978 (dom: 15 may 2020) and 2101195103 (dom: 15 july 2020).The opt944 interface is used to deliver humidified oxygen to patients.The opt944 consists of a lightweight delivery tube which is connected to a rigid plastic base and soft nasal prongs (nasal interface).The interface is held in place by a head strap and also includes a lanyard that is placed around the patient's neck or attached to the patient's clothing or bedding to remove the load of the breathing circuit from the patient's nares.Method: the complaint opt944 optiflow + adult nasal cannula was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the information provided by the customer and our knowledge of the product.Results: the healthcare facility reported that the patient was positive with covid-19 coronavirus disease, hypoxemic, and at end of life.The healthcare facility reported the following sequence of events: on the (b)(6) 2020, a patient desaturated to 75% spo2 when they moved positions resulting in the opt944 optiflow + adult nasal cannula becoming displaced from the patient's nostrils.A healthcare professional corrected the position of the cannula and the patient was returned to a seated position at which point they recovered to 95% spo2.Twenty-four hours later, it was reported that the patient desaturated to below 70% spo2 after the tubing of the optiflow + adult nasal cannula became detached from the cannula connector.Adhesive tape was used to secure the cannula tubing to the cannula connector.The patient was manually mechanically ventilated.The patient later deceased, and no further resuscitation was attempted as the patient was at end of life.It was noted that covid-19 was the medical cause of death.Conclusion: without the complaint device, we were unable to determine the cause of the reported event.The healthcare facility noted that the medical cause of death of the patient was due to covid-19 coronavirus.All optiflow interfaces are inspected during production for visual defects including cracks, tears, inclusions, discoloration and stretching or deformation.Any product that fails the visual inspection is disposed of or reprocessed.The subject opt944 optiflow + adult nasal cannula would have met the required specification at the time of production.The user instructions which accompany the opt944 optiflow + adult nasal cannula show in pictorial format the correct placement and fitting of the cannula and states: "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." "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." the user instructions which accompany the airvo 2 humidifier states: "intended use: the airvo2 is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases." "warning: the unit is not intended for life support." "use continuous oxygen monitoring on patients who would desaturate significantly in the event of disruption to their oxygen supply.".

• Brand Name: OPTIFLOW + ADULT NASAL CANNULA
• Type of Device: BTT
• MDR Report Key: 10971372
• MDR Text Key: 220394846
• Report Number: 9611451-2020-01104
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• 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: SEE H10
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2020
• 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 HEATED BREATHING TUBE KIT; F&P 900PT561 HEATED BREATHING TUBE KIT; F&P PT101 AIRVO 2 HUMIDIFIER; F&P PT101 AIRVO 2 HUMIDIFIER; F&P 900PT561 HEATED BREATHING TUBE KIT; F&P PT101 AIRVO 2 HUMIDIFIER
• Patient Outcome(s): Death