MAUDE Adverse Event Report: BI-LEVEL/CPAP INSPIRATORY HEATED CIRCUIT; BTT

Model Number RT219

Device Problems Disconnection (1171); Misconnection (1399); Improper or Incorrect Procedure or Method (2017)

Patient Problems Low Blood Pressure/ Hypotension (1914); Low Oxygen Saturation (2477)

Event Type  Death  

Manufacturer Narrative

(b)(4).The complaint rt219 adult bi-level/cpap breathing circuit was discarded by the customer.Additional information was requested from the customer to determine the involvement of our product in 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 the rt219 adult bi-level/cpap breathing circuit disconnected from the cpap mask.The user incorrectly reconnected the exhalation port end of the rt017 exhalation port to the cpap mask.It was reported on (b)(6) 2021 that the patient was found with a 21% spo2 level, unresponsive, hypotensive, and required emergency intubation.The patient was then transferred to icu.It was later reported on (b)(6) 2021 that the patient has since passed away.We have requested further information from the healthcare facility to better understand the reported event.

Manufacturer Narrative

(b)(4).Method: the complaint device was requested, however was not returned to fisher & paykel healthcare (f&p) for evaluation.Additional information with regards to the reported event was also requested from the hospital, however limited information was provided.Therefore, our investigation is based on the information provided by the customer and our knowledge of the product.Results: it was reported that the rt219 adult bi-level/cpap breathing circuit disconnected from the bipap mask.It was further reported that the bipap mask was incorrectly reconnected to the exhalation port end of the rt017 exhalation port component.The hospital reported patient desaturation following the event.As part of our follow up of the event and the patients current condition, the patient's death was reported.This does not appear to be related to the incident.The hospital has not provided any further information related to the death.Conclusion: the reported incorrect reconnection of the bipap mask to the exhalation port end of the rt017 exhalation port component was a result of user error.The customer has also stated that the incorrect reconnection was due to user error.There was no reported damage or malfunction with the rt219 breathing circuit.The user instructions that accompany the rt219 bi-level/cpap breathing circuit include a pictorial showing the instructions to connect the circuit and exhalation port correctly.It also includes the following: check all connections are tight before use.Appropriate patient monitoring (e.G.Oxygen saturation) must be used at all times.Failure to monitor the patient (e.G.In the event of an interruption to gas flow) may result in serious harm or death.Ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient.Perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.For use under the supervision of trained medical personnel.

Event Description

A healthcare facility in connecticut reported via a fisher & paykel healthcare (f&p) field representative that the rt219 adult bi-level/cpap breathing circuit disconnected from the cpap mask.The user incorrectly reconnected the exhalation port end of the rt017 exhalation port to the cpap mask.It was reported on (b)(6) 2021 that the patient was found with a 21% spo2 level, unresponsive, hypotensive, and required emergency intubation.The patient was then transferred to icu.It was later reported on (b)(6) 2021 that the patient has since passed away.

• Brand Name: BI-LEVEL/CPAP INSPIRATORY HEATED CIRCUIT
• Type of Device: BTT
• MDR Report Key: 11668187
• MDR Text Key: 245488540
• Report Number: 9611451-2021-00387
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K983112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RT219
• Device Catalogue Number: RT219
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/13/2021
• 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 RT017 EXHALATION PORT.; F&P RT017 EXHALATION PORT.
• Patient Outcome(s): Death; Required Intervention