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

Model Number RT265

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in the process of obtaining further information and the complaint rt265 infant dual heated evaqua2 breathing circuits for evaluation to determine if rt265 caused or contributed to the reported event.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 the swivel of rt265 infant dual-heated evaqua2 breathing circuit came apart.There was no patient consequence.

Manufacturer Narrative

(b)(4).Section d4: lot number: 2100802738 (device manufacture date: 21 jun 2019), 2100855888 (device manufacture date: 17 aug 2019), 2100821981 (device manufacture date: 12 jul 2019).Method: the swivels of six complaint rt265 infant dual heated evaqua2 breathing circuits were returned to fisher & paykel healthcare (f&p) for inspection.Results: visual inspection of devices 1, 2, 3 & 4 revealed that the swivels were returned fully assembled.The pressure tests for these devices confirmed a tight fit of swivel components.Visual inspection of devices 5 and 6 revealed that the swivel elbows and swivel wyes were returned partly disassembled.No damages were observed to any of the swivel components.The swivel elbows and swivel wyes were reassembled.The pressure test for devices 5 and 6 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.".

Event Description

A healthcare facility in canada reported via a fisher & paykel healthcare (f&p) field representative that the swivels of rt265 infant dual-heated evaqua2 breathing circuits came apart.There was no patient consequence.

• Brand Name: INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
• Type of Device: BZE
• MDR Report Key: 9535087
• MDR Text Key: 181957976
• Report Number: 9611451-2019-01267
• 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: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• 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: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Date Manufacturer Received: 02/27/2020
• 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