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

Model Number RT266

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

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint devices are currently en route to fisher & paykel healthcare (f&p) for investigation.We will provide a follow up report upon completion of investigation.

Event Description

A healthcare facility in (b)(6) reported that the swivel wye of rt266 infant dual heated evaqua2 breathing circuits are coming apart with minimal force.There was no reported patient consequences.

Manufacturer Narrative

Ps324644 section d4 lot number.Device 1 and 2: unknown; device 3 - 13: lot number 2100799293 section h4 manufacturing date of device 3 - 13: (b)(6)2019 method: the complaint rt266 infant dual heated evaqua2 breathing circuits were returned to fisher & paykel healthcare for evaluation.Results: visual inspection of the returned complaint devices revealed that the swivel elbow and swivel wye were returned either partly disassembled or fully disassembled.The swivel wyes of complaint devices 2, 3, 4, 5, 6, 8, 9, 11,12, 13 were found damaged.No damages were observed to the swivel components of complaint devices 1, 7, 10.The swivel elbows and swivel wyes were reassembled.The pressure test for the complaint devices 1, 3, 5, 8, 9 confirmed a loose fit of swivel components and the pressure test for the complaint devices 2, 4, 6, 7, 10, 11, 12, 13 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 infant 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 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.".

Event Description

A healthcare facility in washington reported that the swivel wye of rt266 infant dual heated evaqua2 breathing circuits are coming apart with minimal force.There was no reported patient consequences.

• Brand Name: INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
• Type of Device: BZE
• MDR Report Key: 9379615
• MDR Text Key: 178795519
• Report Number: 9611451-2019-01133
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• 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: SEE H10
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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