MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD INFANT BIAS FLOW BREATHING CIRCUIT; BTT

Model Number	RT125
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Method: one complaint rt125 swivel wye connected to a breathing circuit and one complaint rt125 swivel wye without a breathing circuit were returned to fph in (b)(4) and were visually inspected and pressure tested.Results: visual inspection revealed that the ports of both swivel wyes were cracked.The pressure test showed that the swivel wye connected to the breathing circuit was within specification and the swivel wye without a breathing 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 recently been completed and the new pre-mixed material has now been implemented on the production line.All 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 rt125 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 or Problem Description
A hospital in (b)(6) reported via a fisher & paykel healthcare (fph) field representative that the swivel wye of three rt125 infant bias flow breathing circuit had a crack.This was found when the circuits kits were removed from the packaging.There was no patient involvement.

• Brand Name: INFANT BIAS FLOW BREATHING CIRCUIT
• Common Device Name: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 6943168
• Report Number: 9611451-2017-00946
• Device Sequence Number: 19045307
• Product Code: BTT
• UDI-Device Identifier: 09420012431141
• UDI-Public: 010942001243114110
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K020332
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: RT125
• Device Catalogue Number: RT125
• Device Lot Number: 2100208285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2017
• Initial Report FDA Received Date: 10/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1