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

Model Number RT266

Device Problems Air Leak (1008); Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Date 05/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint rt266 breathing circuit is currently en route to fisher & paykel healthcare (b)(4) for evaluation.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 field representative that an rt266 dual limb infant breathing circuit had leaked during the initial ventilator test due to a crack in the circuit connector.There was no patient involvement.

Manufacturer Narrative

(b)(4).Method: the complaint rt266 infant dual heated evaqua2 breathing circuit's swivel was returned to fisher & paykel healthcare in new zealand for investigation and was visually inspected.Results: visual inspection revealed a crack along one of the swivel ports.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.The new pre-mixed material has now been implemented on the production line.The subject circuits were manufactured prior to the production change.All rt266 infant dual heated evaqua2 breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.Our user instructions that accompany the rt266 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 sweden reported via a fisher & paykel healthcare field representative that an rt266 dual limb infant breathing circuit had leaked during the initial ventilator test due to a crack in the circuit connector.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: 7551735
• MDR Text Key: 109486639
• Report Number: 9611451-2018-00462
• 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: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2018
• 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: 2100110968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1