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

Model Number RT265

Device Problems Disconnection (1171); Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in the process of obtaining the two complaint rt265 infant dual heated evaqua2 breathing circuits for evaluation.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 two rt265 infant dual heated evaqua2 breathing circuit swivels were found separated during patient use.There was no reported patient consequence.

Event Description

A healthcare facility in australia reported, via a fisher & paykel healthcare (f&p) field representative, that two rt265 infant dualheated evaqua2 breathing circuit swivels were found separated during patient use.There was no reported patient consequence.

Manufacturer Narrative

(b)(4).Method: the swivels from the complaint rt265 infant dual heated evaqua2 breathing circuits were returned to fisher & paykel healthcare for evaluation.Results: visual inspection for device 1 revealed that the swivel elbow and swivel wye were returned partly disassembled.Damage was observed to the swivel elbow and no damage was observed to the swivel wye.The swivel elbow and swivel wye were reassembled.The pressure test for the complaint device confirmed a tight fit of swivel components.Visual inspection for device 2 revealed that the swivel elbow and swivel wye were returned disassembled.Damage was observed to swivel wye.No damage was observed to swivel elbow.The swivel elbow and swivel wye were reassembled.The pressure test for the complaint device confirmed a tight fit of swivel components.Conclusion: investigation into this complaint reviewed the manufacturing process (operator, equipment, measurement and environment), process documentation, samples of product, complaint devices and performed a material analysis.The investigation indicated a potential resin material mix-up was the most likely cause.We have since implemented an additional material verification step, at the point of resin material addition to the moulding machine feed.This verification would identify any potential resin material mix-up prior to use.All rt265 dual-heated evaqua2 breathing circuits are designed to conform to iso:5367.All rt265 circuits are visually inspected, pressure and flow tested during production and those that fail, are rejected.The user instructions that accompany the rt265 infant dual heated evaqua2 breathing circuit 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: 9420609
• MDR Text Key: 179292057
• Report Number: 9611451-2019-01169
• Device Sequence Number: 1
• Product Code: BZE
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT265
• Device Catalogue Number: RT265
• Device Lot Number: 2100877303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2019
• Date Manufacturer Received: 02/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2019
• 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