MAUDE Adverse Event Report: HEATED BREATHING TUBE AND CHAMBER KIT; BTT

Model Number 900PT561

Device Problem Break (1069)

Patient Problems Low Oxygen Saturation (2477); Fibrosis (3167); Cancer (3262)

Event Type  Death  

Manufacturer Narrative

(b)(4).We are in the process of retrieving further information and the f&p devices involved with regards to this reported event.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in the (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that a patient receiving palliative care passed away overnight in his home bed whilst using a pt100 myairvo 2 humidifier, 900pt561 heated breathing tube and chamber kit, and an opt944 optiflow + adult nasal cannula.It was further reported that the patient was not being monitored during the night and was found deceased in the morning.The heated breathing tube, as part of the 900pt561 kit, was found damaged.The healthcare facility reported that the medical cause of death was pulmonary fibrosis and malignant neoplasm lung cancer.We are in the process of retrieving further information and the f&p devices involved with regards to this reported event.

Manufacturer Narrative

(b)(4).Method: f&p contacted the healthcare facility multiple times to obtain further information and requested the return of the devices involved in the reported event.However, no further information or devices, including the complaint 900pt561 heated breathing tube (as part of the heated breathing tube and chamber kit) was returned for evaluation.Our investigation is thus based on the photograph and information provided by the healthcare facility, and our knowledge of the product.Result: visual inspection of the photograph provided revealed that the tubing of the 900pt561 heated breathing tube was split near the patient end and in the middle of the tube.Conclusion: without the return of the devices involved in the reported event, we are unable to determine the cause of the reported event.Damage to the heated breathing tube may be caused by factors such as incorrect set-up, subjecting it to excessive force, inappropriate cleaning, covering it with a material with a temperature greater than that of typical room conditions and /or being under compressive load for a considerable length of time.It is noted that the patient was 95 years old and was being provided with palliative care.The healthcare facility stated that the medical cause of death was pulmonary fibrosis and malignant neoplasm lung cancer.It is also noted that the patient was not being monitored.All heated breathing tubes as part of the 900pt561 heated breathing tube and chamber kits are visually inspected and undergo functional tests, including soak, temperature, and heater wire resistance.The subject heated breathing tube would have met the required specifications at the time of production.The 900pt561 user instructions includes the following, cautions and warnings: "never operate the unit if the breathing tube has been damaged with holes, tears or kinks" "do not block the flow of air through the unit and breathing tube." "do not soak, wash or sterilize." "avoid contact with chemicals, cleaning agents, or hand sanitizers" "this product is not intended for use with any medication." "do not add heat to any part of the breathing tube e.G., covering with a blanket[?]as this could result in serious injury." "this product is intended to be used for a maximum of 60 days for home use, provided that the myairvo/myairvo 2 cleaning and maintenance instructions are followed." the myairvo 2 humidifier user manual provides instructions for cleaning and maintenance including daily and weekly cleaning, followed by schedule for changing accessories, it also states: "myairvo 2 is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases" "the unit is not intended for life support." "appropriate patient monitoring must be used at all times.".

Event Description

A healthcare facility in the united kingdom reported via a fisher & paykel healthcare (f&p) field representative that a patient receiving palliative care passed away overnight in his home bed whilst using a pt100 myairvo 2 humidifier, 900pt561 heated breathing tube and chamber kit, and an opt944 optiflow + adult nasal cannula.It was further reported that the patient was not being monitored during the night and was found deceased in the morning.The heated breathing tube, as part of the 900pt561 kit, was found damaged.The healthcare facility reported that the medical cause of death was pulmonary fibrosis and malignant neoplasm lung cancer.

• Brand Name: HEATED BREATHING TUBE AND CHAMBER KIT
• Type of Device: BTT
• MDR Report Key: 12192797
• MDR Text Key: 262387232
• Report Number: 9611451-2021-00760
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012433794
• UDI-Public: (01)09420012433794(10)2101077152(11)200416
• Combination Product (y/n): N
• PMA/PMN Number: K162553
• 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: 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 900PT561
• Device Catalogue Number: 900PT561
• Device Lot Number: 2101077152
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: F&P OPT944 OPTIFLOW + ADULT NASAL CANNULA; F&P OPT944 OPTIFLOW + ADULT NASAL CANNULA; F&P PT100 MYAIRVO 2 HUMIDIFIER; F&P PT100 MYAIRVO 2 HUMIDIFIER
• Patient Outcome(s): Death
• Patient Age: 95 YR