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

Model Number RT266

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/31/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint rt266 infant dual heated evaqua2 breathing circuit was returned to fisher & paykel healthcare (f&p) in (b)(4), where it was visually inspected and pressure tested.Results: the swivel elbow and swivel wye were returned partly disassembled.Damage was observed to the swivel wye.The swivel was reassembled together and formed a tight fit.Pressure test revealed that the returned rt266 swivel assembly was within specification.Conclusion: we could not determine what caused the rt266 swivel to disassemble.The infant swivel was assembled using a machine to ensure a consistent tightness of connection.The swivel is then 100% pressure and flow tested as part of the infant breathing circuit before leaving the production line.Any breathing circuits that fail these tests are rejected.The subject breathing circuits would have met the requirements at the time of production.Our user instructions that accompany the rt266 infant dual heated evaqua2 breathing circuit 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.".

Event Description

A healthcare facility in (b)(6) reported that the swivel of a rt266 infant dual heated evaqua2 breathing circuit disassembled during use.There was no patient consequences.

Event Description

A healthcare facility in (b)(6) reported that the swivel of a (b)(4) infant dual heated evaqua2 breathing circuit disassembled during use.There was no patient consequences.

Manufacturer Narrative

(b)(4).Follow up report due to additional information.Updated h6 results and conclusion code.Updated h10 conclusion.Method: the complaint (b)(4) infant dual heated evaqua2 breathing circuit was returned to fisher & paykel healthcare (f&p) in new zealand, where it was visually inspected and pressure tested.Results: the swivel elbow and swivel wye were returned partly disassembled.Damage was observed to the swivel wye.The swivel was reassembled together and formed a tight fit.Pressure test revealed that the returned (b)(4) swivel assembly was within specification.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 (b)(4) dual-heated evaqua2 breathing circuits are designed to conform to iso:5367.All (b)(4) 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 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: 9470719
• MDR Text Key: 181539666
• Report Number: 9611451-2019-01199
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2019
• 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: 2100799293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Date Manufacturer Received: 02/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2019
• 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