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

Model Number RT265

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

Patient Problems Bradycardia (1751); Low Oxygen Saturation (2477)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint rt265 infant dual heated evaqua2 breathing circuit was received at fisher & paykel healthcare (f&p) in (b)(4) for evaluation.We are in process to determine if f&p's product caused or contributed to the reported event.We will provide a follow-up report upon completion of our investigation.

Event Description

A hospital in (b)(6) reported via a fisher & paykel healthcare representative that the swivel of the rt265 infant dual-heated evaqua2 breathing circuit came apart during use.It was reported that the patient desaturated and showed bradycardia.No further consequences were reported.

Manufacturer Narrative

Ps318480 method: the complaint rt265 infant dual heated evaqua2 breathing circuit was returned to fisher & paykel healthcare for evaluation.Results: the swivel elbow and swivel wye were returned partly disassembled.No damages were observed to any of the swivel components.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 infant dual-heated evaqua2 breathing circuits are visually inspected and 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 hospital in australia reported via a fisher & paykel healthcare representative that the swivel of the rt265 infant dual-heated evaqua2 breathing circuit came apart during use.It was reported that the patient desaturated and showed bradycardia.No further consequences were reported.

• Brand Name: INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
• Type of Device: BZE
• MDR Report Key: 9014070
• MDR Text Key: 176280727
• Report Number: 9611451-2019-00875
• 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: 08/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• 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: 2100802738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2019
• Date Manufacturer Received: 02/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2019
• 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