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

Model Number RT319

Device Problems Disconnection (1171); Unintended Ejection (1234); Misconnection (1399); Improper or Incorrect Procedure or Method (2017); Connection Problem (2900)

Patient Problem Low Oxygen Saturation (2477)

Event Date 07/20/2021

Event Type  Death  

Manufacturer Narrative

(b)(4).We are currently in the process of finalising our investigation.We will provide a follow up report upon completion of investigation.

Event Description

A distributor reported on behalf of healthcare facility in (b)(6) that the rt319 adult bi-level cpap breathing circuit disconnected from a non-invasive ventilation (niv) mask and the ventilator's alarm was triggered.A nurse responded to the alarm and incorrectly reconnected the niv mask to the rt017 exhalation port.Following the incorrect connection, the patient's oxygen saturation (spo2) had dropped to 68% and the patient had respiratory distress.The nurse then noticed a high leak on the ventilator, and another nurse came and corrected the connection.After the connector was corrected, the patient recovered to 91% spo2.The rt319 adult bi-level cpap breathing circuit was continued to be used.It was later reported that the patient passed away on (b)(6) , 3 days after the event as a result of "primary disease at admission".

Manufacturer Narrative

(b)(4).Method: the complaint rt319 bi-level/cpap breathing circuit was not returned to fisher & paykel healthcare (f&p) for evaluation.Additional information with regards to the reported event and patient outcome 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: the customer reported that the rt319 adult bi-level cpap breathing circuit disconnected from a non-invasive ventilation (niv) mask and the ventilator's alarm was triggered.A nurse responded to the alarm and incorrectly reconnected the niv mask to the rt017 exhalation port.Following the incorrect connection, the patient's oxygen saturation (spo2) had dropped to 68% and the patient had respiratory distress.The nurse then noticed a high leak on the ventilator, and another nurse came and corrected the connection.After the connector was corrected, the patient recovered to 91% spo2.Use of the rt319 adult bi-level cpap breathing circuit continued following the event.It was further reported that the patient passed away on 23 july, 3 days after the event as a result of "primary disease at admission".Based on the information provided, there is no indication of any causal relationship between the patient death and the reported disconnection and misconnection.It should be noted that the patient had a "do-not-resuscitate" order.Conclusion: without the return of the subject device, we are unable to determine the cause of the disconnection.Furthermore, there was no reported damage or malfunction with the rt319 bi-level/cpap breathing circuit.The reported misconnection of the niv mask to the exhalation port was as a result of user error.The user instructions that accompany the rt319 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.For use under the supervision of trained medical personnel.Before connecting to patient, ensure that flow and pressure testing applicable to the ventilator has been completed.

Event Description

A distributor reported on behalf of healthcare facility in japan that the rt319 adult bi-level cpap breathing circuit disconnected from a non-invasive ventilation (niv) mask and the ventilator's alarm was triggered.A nurse responded to the alarm and incorrectly reconnected the niv mask to the rt017 exhalation port.Following the incorrect connection, the patient's oxygen saturation (spo2) had dropped to 68% and the patient had respiratory distress.The nurse then noticed a high leak on the ventilator, and another nurse came and corrected the connection.After the connector was corrected, the patient recovered to 91% spo2.Use of the rt319 adult bi-level cpap breathing circuit continued following the event.It was later reported that the patient passed away on (b)(6) 2021, 3 days after the event as a result of "primary disease at admission".

• Brand Name: BI-LEVEL/CPAP INSPIRATORY HEATED CIRCUIT
• Type of Device: BTT
• MDR Report Key: 12346196
• MDR Text Key: 267408477
• Report Number: 9611451-2021-00937
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012430342
• UDI-Public: (01)09420012430342(10)2101216120(11)20072
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RT319
• Device Catalogue Number: RT319
• Device Lot Number: 2101216120
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2020
• 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: PHILIPS V60 VENTILATOR; PHILIPS V60 VENTILATOR; PHILIPS V60 VENTILATOR
• Patient Outcome(s): Death
• Patient Age: 63 YR