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

Model Number RT266

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem Tachycardia (2095)

Event Date 09/09/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint rt266 infant dual heated evaqua2 breathing circuit is en route to fisher & paykel healthcare in (b)(4) for investigation.We will provide a follow-up report once we have completed our investigation.

Event Description

A healthcare facility in (b)(6) reported to a fisher & paykel healthcare (fph) field representative that the y-piece of an rt266 infant dual heated evaqua2 breathing circuit was found cracked and leaking while being used on a child.It was also reported that the child was tachypneic and tachycardic, and it took a while before it was discovered that the problem was due to the leak on the y-piece.No other patient consequence was reported as a result of this incident.

Manufacturer Narrative

(b)(4).Method: the complaint rt266 infant dual heated evaqua2 breathing circuit was returned to fph in (b)(4) for inspection.It was visually inspected and pressure tested.Results: visual inspection revealed a crack along one of the swivel wye ports.The pressure test result was also outside of the specification.A lot check revealed no other complaints of this nature for lot number 151214.Conclusion: we are unable to determine the root cause of the fault reported by the healthcare facility.All rt266 infant dual heated evaqua2 breathing circuits are visually inspected, and pressure and flow tested during production, and those that fail are rejected.The subject infant breathing circuit would have met the required specification at the time of production.Moreover, the healthcare facility reported that it passed the ventilator leak test and that the damage occurred after a period of use, which suggest that the observed cracking occurred after the subject rt266 infant breathing circuit was released for distribution.The user instructions that accompany the rt266 infant dual heated evaqua2 breathing circuit illustrate in pictorial format the correct set-up and proper use of the breathing circuit kit.It also states 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 healthcare facility in (b)(4) reported to a fisher & paykel healthcare (fph) field representative that the y-piece of an rt266 infant dual heated evaqua2 breathing circuit was found cracked and leaking while being used on a child.It was also reported that the child was tachypneic and tachycardic, and it took a while before it was discovered that the problem was due to the leak on the y-piece.No other patient consequence was reported as a result of this incident.

• Brand Name: INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
• Type of Device: BZE
• 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 ; 173 technology dr., suite 100; irvine; 9494534000
• MDR Report Key: 6077349
• MDR Text Key: 59133787
• Report Number: 9611451-2016-00736
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K103767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2016
• 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: 151214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2015
• 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