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

Model Number RT266

Device Problems Air Leak (1008); Disconnection (1171); Device Displays Incorrect Message (2591)

Patient Problems Respiratory Distress (2045); Tachycardia (2095)

Event Date 11/06/2014

Event Type  malfunction  

Event Description

A hospital in (b)(6) state reported via a fisher & paykel healthcare representative that an rt266 circuit was leaking during use.The circuit was used on an infant and the ventilator was alarming, indicating a leak in the system.While removing the circuit from the patient the respiratory therapist found the swivel wye disconnected from the swivel elbow.The patient began to experience tachycardia and increased respiratory rate due to the leak.Manual infant resuscitation was performed while changing out the circuit.The patient was stabilised with no further consequence.

Manufacturer Narrative

(b)(4).Method: the complaint rt266 breathing circuit was returned to fisher & paykel healthcare (b)(4).The breathing circuit was visually inspected and pressure tested.Results: visual examination revealed that the swivel wye and swivel elbow were not properly fitted together when the breathing circuit was received for investigation.The pressure tests showed that the returned circuit was within specification when the swivel wye and swivel elbow were connected.A lot check was not performed as a lot number was not provided.Conclusion: we were unable to determine what has caused the disconnection of the swivel wye and elbow.All rt266 infant dual-heated evaqua2 breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.This is an automated process and the breathing circuit would have met the required specification when released for distribution.It is possible that the connection became loose during transport to or storage at the customer facility.The 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.

• 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
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: raymond yan ; 15365 barranca parkway; irvine, CA 92618-2216 ; 9494534000
• MDR Report Key: 4288580
• MDR Text Key: 18069085
• Report Number: 9611451-2014-00874
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/07/2014

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
• Device Operator: Health Professional
• Device Model Number: RT266
• Device Catalogue Number: RT266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/07/2014
• Initial Date FDA Received: 12/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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