MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT; BZE

Model Number RT265

Device Problems Break (1069); Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint (b)(4) breathing circuit is currently en route to fisher & paykel healthcare (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 (f&p) field representative that they found a broken swivel wye of an rt265 infant dual-heated evaqua2 breathing circuit when checking it before use.There was no patient involvement.

Manufacturer Narrative

Method: the complaint rt265 breathing circuit was returned to fisher & paykel healthcare in new zealand for evaluation.The returned circuit was visually inspected and pressure tested.Results: visual inspection revealed that the swivel was cracked along one of the swivel wye ports.The pressure test revealed that the circuit was outside of specification.Conclusion: investigations into this issue have determined that the cracking has most likely occurred due to improperly mixed material in the batch.We have since contacted the supplier and arranged for them to supply the molding material with the two parts already mixed.We anticipate that this will resolve the issue and the project to implement this change has been completed with the new pre-mixed material having been implemented on the production line.All rt265 infant breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.Our user instructions that accompany the rt265 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 spain reported via a fisher & paykel healthcare (f&p) field representative that they found a broken swivel wye of an rt265 infant dual-heated evaqua2 breathing circuit when checking it before use.There was no patient involvement.

• Brand Name: INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
• Type of Device: BZE
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 8183200
• MDR Text Key: 131499165
• Report Number: 9611451-2018-01098
• 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: 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• 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: 2100485311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2019
• Date Manufacturer Received: 11/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1