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

Model Number RT265

Device Problem Crack (1135)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4) method: the inspiratory limbs, expiratory limbs and swivel wyes of six out of seven affected rt265 infant dual heated evaqua2 breathing circuits were returned to (b)(4) for evaluation.The returned devices were visually inspected and pressure tested for leaks.Results: visual inspection revealed that the proximal connector collar was cracked on all six expiratory limbs.Residue and stain were also observed on the returned devices.Two inspiratory limbs were also damaged.Only four of the six returned breathing circuits passed the pressure leak test.A lot check was not performed as lot information was not provided.Conclusion: based on the nature of the observed cracking and previous investigations into this type of failure, the cracking is most likely due to the connectors coming into contact with a cleaning chemical, resulting in environmental stress cracking.All rt265 infant dual heated evaqua2 breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The healthcare facility reported that the damage was observed during use, which suggests that the complaint breathing circuits became damaged after they were released for distribution.Our 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 occlusions before connecting to a patient." "set appropriate ventilator alarms." the user instructions also state the following: "do not soak, wash, sterilize or reuse this product.Avoid contact with chemicals, cleaning agents or hand sanitizers.".

Event Description

A healthcare facility in (b)(6) reported to a fisher & paykel healthcare (fph) field representative that the collar of the expiratory limb of an rt265 infant dual heated evaqua2 breathing circuit was found cracked during use.This was also observed on six other rt265 infant breathing circuits.No patient consequence was reported.

• 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: 5255675
• MDR Text Key: 32395694
• Report Number: 9611451-2015-00510
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K103767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2015
• 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: NO PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2015
• Date Manufacturer Received: 11/03/2015
• 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