MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED INFANT CONTINUOUS FLOW BREATHING CIRCUIT; BTT

Model Number RT329

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A hospital in the (b)(6) reported via a fisher & paykel healthcare (fph) representative that the pressure relief valve of an rt329 infant continuous flow breathing circuit came off.This was reported to have occurred on two occasions where a baby then desaturated.No further patient consequences were reported.

Manufacturer Narrative

(b)(4).The complaint rt329 breathing circuit was not returned to fph.Return of the device was requested and questions were sent to the hospital regarding the event.A lot check could not be performed as the lot number was not provided.Conclusion: the rt329 infant continuous flow breathing circuit kit includes a pressure relief manifold which ensures patient safety by limiting the pressure delivered in the event of an occlusion, as well as allowing connection to a pressure monitoring device or an oxygen analyzer.The manifold is packed with the luer port cap in place.All pressure manifolds are pressure tested and visually inspected prior to leaving our facility, and those that fail are rejected.This suggests that the port cap became loose post production.Based on previous investigations it is most likely that the luer port cap was not being firmly enough seated in the port, leading to the port loosening and then coming off the port during use.The luer port cap is designed to be removable for users to attach a pressure monitoring device or an oxygen analyser if required, and thus our user instructions instruct the user to check that the luer port cap is tight when the port is not needed.As part of our ongoing product improvement initiatives to implement an insertion machine to standardise and increase the insertion force of the luer port cap was introduced to the pressure relief manifold production line on (b)(4) 2013.Our user instructions that accompany the rt329 infant continuous flow breathing circuit state the following: -"check that all connections, caps and/or plugs are tight before use." -"perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient." -"patient monitoring is recommended.".

• Brand Name: INFANT CONTINUOUS FLOW BREATHING CIRCUIT
• Type of Device: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer Contact: raymond yan ; 15365 barranca parkway; irvine; 9494534000
• MDR Report Key: 3819540
• MDR Text Key: 4499994
• Report Number: 9611451-2014-00426
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K020332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT329
• Device Catalogue Number: RT329
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/23/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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