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

Model Number RT265

Device Problems Material Separation (1562); Device Displays Incorrect Message (2591)

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

Event Date 01/03/2014

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported to a fisher & paykel healthcare (fph) field representative that the manifold of an rt265 infant dual heated evaqua2 breathing circuit came apart, causing a "low pressure" alarm on the ventilator.This was observed during use on a patient; however, no patient consequence was reported.

Manufacturer Narrative

(b)(4).Method: only the swivel y-piece and the swivel elbow of the complaint rt265 infant dual heated evaqua2 breathing circuit were returned to fph in (b)(4) for inspection.The swivel components were detached from each other.The returned components were visually inspected and pressure tested for the reported leaks.The swivel y-piece and its elbow were reassembled to a known good sample breathing circuit before the pressure test.Results: visual inspection revealed that there was a damage in a section of the sealing area of the swivel.The pressure test result was within specification.A lot check revealed no other complaints of this nature for lot number 130816.Conclusion: we were unable to determine definitively the root cause of the reported leak; however, the damage in the sealing area of the swivel suggests that it sustained physical damage.The swivel assembly of each infant breathing circuit is visually inspected, and pressure and flow tested during production, and those that fail are rejected.This suggests that the subject swivel y-piece was damaged after the complaint rt265 infant dual heated evaqua2 breathing circuit was released for distribution.The user instructions that accompany the rt265 infant dual heated evaqua2 breathing circuit state the following: "check all connections are tight before use." "perform a pressure and leak test on the breathing system and check for occlusion 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 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: 3625425
• MDR Text Key: 4133813
• Report Number: 9611451-2014-00119
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K103767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/16/2014

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: RT265
• Device Catalogue Number: RT265
• Device Lot Number: 130816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2014
• Initial Date FDA Received: 02/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2013
• 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