MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT; BZE

Model Number RT380

Device Problems Disconnection (1171); Use of Device Problem (1670)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

(b)(4).Method: the complaint rt380 dual-heated adult breathing circuit was not returned to fisher & paykel healthcare for evaluation.Our investigation is based on the information provided by the customer and our knowledge of the product.Results: the customer reported that the inspiratory limb of a rt380 dual-heated adult breathing circuit disconnected from the y-piece.The patient was covid-19 positive, therefore the patient was in isolation with the door of the room closed.As such the hospital did not hear or respond to the ventilator alarms.The customer reported that the connections to the circuit were taped and the patient was treated with high pressure on pcv and high peep.The patient was positioned in the supine position.The customer reported that it was likely an accidental disconnection from the ventilator.Conclusion: without the complaint device, we are unable to determine the cause of the reported patient incident.However, it is likely the circuit accidentally disconnected as a result of being under tension due to patient movement or the connector not being fitted tightly and not being visible under the tape.Since then, they have committed to ensuring secure breathing circuit connections in the future, refrain from using tape on circuit connections to avoid missing a possible loose connection under the tape, and implementing improved systems for covid-19 patient monitoring.All rt380 adult dual-heated breathing circuits are visually inspected and pressure tested before leaving the production line, and those that fail are rejected.The user instructions that accompany the rt380 dual-heated adult breathing circuit state the following: "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.Failure to comply with any of the following warnings may impair performance of the device or compromise safety (including potentially causing serious harm)"."ensure appropriate ventilator or flow source alarms re set before connecting breathing set to patient"."perform a pressure and leak test on the breathing system and check for occlusions before connection to patient"."check all connections are tight before use"."for use under the supervision of trained medical personnel"."the responsible organization is accountable for the compatibility of the humidifier and all of the parts and accessories used to connect to the patient and other equipment before use".

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that the inspiratory limb of a rt380 dual-heated adult breathing circuit disconnected from the y-piece while set-up on a patient.It was reported that the patient was isolated as they were being treated for covid-19.As such the hospital did not hear or respond to the ventilator alarms and the patient deceased.The customer has indicated that due to the isolation of the covid-19 patient, they did not respond to the ventilator alarms.Since the incident, the customer has committed to ensuring secure breathing circuit connections in the future and implementing improved systems for covid-19 patient monitoring.

• Brand Name: ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
• Type of Device: BZE
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 10760306
• MDR Text Key: 213842936
• Report Number: 9611451-2020-00947
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• PMA/PMN Number: K122432
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RT380
• Device Catalogue Number: RT380
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/01/2020
• 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
• Patient Outcome(s): Death