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

Model Number RT266

Device Problems Leak/Splash (1354); Connection Problem (2900); Gas/Air Leak (2946)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/26/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint rt266 infant dual heated evaqua2 breathing circuits are currently en-route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow up report upon completion of investigation.

Event Description

A distributor reported on behalf of a healthcare facility in (b)(6) that the dryline of three rt266 infant dual-heated evaqua2 breathing circuits were found with incorrect connectors.On 29 november 2021, an investigation was completed indicating that the malfunction would result in a leak.There was no patient involvement.

Event Description

A healthcare facility in michigan reported via a fisher and paykel healthcare (f&p) field representative that a rt265 infant dual heated evaqua2 breathing circuit failed the leak test.It was leaking around the swivel.There was no patient involvement.

Manufacturer Narrative

(b)(4).Method: the complaint rt265 infant dual-heated evaqua2 breathing circuit was returned to fisher & paykel healthcare (f&p) in new zealand, where it was visually inspected and pressure tested.Results: visual inspection of the complaint rt265 infant dual-heated evaqua2 breathing circuit revealed no damage to the returned breathing circuit or the dryline.The pressure test also revealed that the breathing circuit was within specification.Conclusion: we were unable to determine what may have caused the failed leak test as reported by the customer, as no fault was found with the returned device.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 subject infant breathing circuit would have met the required specifications at the time of production.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.".

Event Description

A distributor reported on behalf of a healthcare facility in south korea that the dryline of three rt266 infant dual-heated evaqua2 breathing circuits were found with incorrect connectors.The incorrect connector was found before use when setting the circuit up on the ventilator.There was no patient involvement.

Manufacturer Narrative

Correction: the previous report submitted under follow up 1 submitted under mfr# 9611451-2021-01453 was incorrectly submitted.(b)(4).Method: the complaint rt266 infant dual-heated evaqua2 breathing circuits were returned to fisher & paykel healthcare (f&p) in new zealand, where it was visually inspected.Results: visual inspection of the complaint rt266 infant dual-heated evaqua2 breathing circuits revealed the incorrect connector was found assembled to the ventilator side of the dryline.Conclusion: the connector was incorrectly assembled during production.An incorrectly assembled circuit would be detected prior to use on a patient, either during set up (cannot connect) or during the pre-functional set up tests (fails leak and pressure test).Our user instructions that accompany the rt266 infant dual heated evaqua2 breathing circuit state "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient".Our user instructions also state - "check all connections are tight before use." - "visually inspect breathing sets for damage (e.G.A crushed tube or cracked connector) before use and replace if damaged." - "ensure appropriate ventilator or flow source alarms are set before connecting breathing set to 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: farnak gomarooni ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 13099044
• MDR Text Key: 285716002
• Report Number: 9611451-2021-01453
• Device Sequence Number: 1
• Product Code: BZE
• UDI-Device Identifier: 09420012431103
• UDI-Public: (01)09420012431103(10)2101725071(11)210716
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 11/29/2021

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
• Device Lot Number: 2101725071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2021
• Initial Date FDA Received: 12/28/2021
• Supplement Dates Manufacturer Received: 02/10/2022; 02/10/2022
• Supplement Dates FDA Received: 01/18/2022; 03/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2021
• 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