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

Model Number RT266

Device Problems Disconnection (1171); Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently attempting to obtain the complaint devices for evaluation to determine if our product 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 field representative that the portion of rt266 infant dual heated evaqua 2 breathing circuit caused a gas leaking during use.There was no patient consequences.

Event Description

A healthcare facility in illinois reported via a fisher & paykel healthcare field representative that the portion of rt266 infant dual heated evaqua 2 breathing circuit caused a gas leak during use.There was no patient consequences.

Manufacturer Narrative

(b)(4).Method: two complaint devices and two sealed rt266 infant dual heated evaqua2 breathing circuits were returned to fisher & paykel healthcare (f&p) new zealand for investigation.Results: the first complaint device was returned with the swivel wye, however the swivel elbow was not returned.No damage was observed to the swivel wye.The second complaint rt266 circuit was returned without the swivel.Visual inspection of the returned two sealed rt266 revealed that the swivel elbow and swivel wye were returned disassembled.Damage was observed to both swivel wyes.The swivel elbows and swivel wyes were reassembled and confirmed a tight fit of the 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.The rt266 dual-heated evaqua2 breathing circuits are designed to conform to (b)(4).All rt266 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: 9730973
• MDR Text Key: 183955613
• Report Number: 9611451-2020-00174
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• 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: 03/06/2020
• Date Manufacturer Received: 03/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2019
• 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