MAUDE Adverse Event Report: INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT; BZE

Model Number RT266

Device Problem Disconnection (1171)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A distributor reported on behalf of a healthcare facility in (b)(6) that the connector of a rt266 infant dual-heated evaqua2 breathing circuit was disconnected before use.It was identified when the circuit was taken out of box.There was no patient involvement.

Event Description

A distributor reported on behalf of a healthcare facility in japan that the connector of a rt266 infant dual-heated evaqua2 breathing circuit was disconnected before use.There was no patient involvement.

Manufacturer Narrative

(b)(4).Method: the complaint rt266 infant dual heated evaqua2 breathing circuit was returned to fisher & paykel healthcare (f&p) in new zealand where it was visuall inspected and pressure tested.Results: visual inspection was performed and the elbow and swivel wye were returned disassembled.No damage was observed to the swivel wye or elbow and the assembled parts.The reassembled parts of the swivel formed a tight fit.Pressure testing revealed that the swivel was manufactured within specifications.Conclusion: we are unable to determine what caused the rt266 swivel to disassemble.The infant swivel is assembled using a machine to ensure a consistent tightness of connection.Furthermore, the swivel was manufactured within specifications.The rt266 dual-heated evaqua2 breathing circuits are designed to conform to iso:5367.All circuits are visually inspected, pressure and flow tested during production and those that fail, are rejected.The user instructions that accompany the rt266 infant dual heated evaqua2 breathing circuits also state the following: "check all connections are tight before use." "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient." "set appropriate ventilator alarms.'.

• Brand Name: INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
• Type of Device: BZE
• MDR Report Key: 11626277
• MDR Text Key: 245826234
• Report Number: 9611451-2021-00376
• Device Sequence Number: 1
• Product Code: BZE
• UDI-Device Identifier: 09420012431103
• UDI-Public: (01)09420012431103(10)2101338445(11)201014
• Combination Product (y/n): N
• PMA/PMN Number: K103767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT266
• Device Catalogue Number: RT266
• Device Lot Number: 2101338445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Initial Date Manufacturer Received: 03/08/2021
• Initial Date FDA Received: 04/07/2021
• Supplement Dates Manufacturer Received: 07/30/2021
• Supplement Dates FDA Received: 08/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2020
• 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