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

Model Number RT266

Device Problem Hole In Material (1293)

Patient Problem No Patient Involvement (2645)

Event Date 06/26/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint rt266 infant dual heated evaqua2 breathing circuits were not returned to fisher & paykel healthcare in (b)(4) for investigation.Our analysis is accordingly based on the information and photographs provided by the healthcare facility, and the results of previous investigations on similar complaints.Results: the photographs provided by the healthcare facility showed that there were multiple holes in the inspiratory and expiratory limb of the circuits.Conclusion: we were unable to determine what may have caused the damage found to the complaint circuits.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 suggests that the damage occurred to the circuit after it was released for distribution.Our user instructions that accompany the rt266 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.- do not soak, wash, sterilize or reuse this product.Avoid contact with chemicals, cleaning agents or hand sanitisers.

Event Description

A distributor in india reported to a fisher & paykel healthcare field representative that holes were found in the tubing of rt266 infant dual heated evaqua2 breathing circuits.The units failed the initial leak test before use on a patient.No patient involvement was reported.

Manufacturer Narrative

(b)(4).Method: twelve rt266 infant dual heated evaqua2 breathing circuits were returned to fisher & paykel healthcare in (b)(6) for investigation and were visually inspected.Our investigation is also based on similar complaints received from the same distributor.Results: visual inspection revealed multiple holes in the inspiratory and/or expiratory limbs of eight breathing circuits.No fault was found with the remaining four breathing circuits.The packaging of all returned breathing circuits was damaged.Conclusion: the complaint breathing circuits were caused by abrasion, most likely due to transport or storage conditions.Scanning electron microscopy (sem) was performed on similar complaint devices from the same distributor.Sem revealed that the packaging and circuit tubing had been subjected to an external abrasion source, which supports our current investigation findings.All rt266 infant dual heated evaqua2 breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.In addition, the packaged breathing circuits are visually inspected for damage before being carefully packed into cartons.This suggests the complaint breathing circuits were damaged after they had been released for distribution.Our user instructions that accompany the rt266 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.Do not soak, wash, sterilize or reuse this product.Avoid contact with chemicals, cleaning agents or hand sanitizers.

Event Description

A distributor in (b)(6) reported to a fisher & paykel healthcare field representative that holes were found in the tubing of rt266 infant dual heated evaqua2 breathing circuits.The units failed the initial leak test before use on a patient.

• 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: sharon kuruvilla ; 173 technology dr. suite 100; irvine, CA 92618 ; 8007923912
• MDR Report Key: 6742994
• MDR Text Key: 81132715
• Report Number: 9611451-2017-00673
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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,Followup
• Report Date: 06/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2017
• 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: 2100099837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2016
• 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