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

Model Number RT266

Device Problems Leak/Splash (1354); Misassembled (1398)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint (b)(4) 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 healthcare facility in (b)(6) reported that the dryline of eight (b)(4) infant dual-heated evaqua2 breathing circuits were found with incorrect connectors.On (b)(6) 2021, an investigation was completed indicating that the malfunction would result in a leak.There was no patient involvement.

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 healthcare facility in (b)(6) reported that the dryline of eight 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 (b)(6) reported that the dryline of eight 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.

Manufacturer Narrative

(b)(4).Method: the complaint rt266 infant dual-heated evaqua2 breathing circuits were returned to fisher & paykel healthcare (f&p) in new zealand, where they were visually inspected.Results: visual inspection of the complaint rt266 infant dual-heated evaqua2 breathing circuits revealed the incorrect connectors were 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 the following: - "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: faranak gomarooni ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534000
• MDR Report Key: 13050283
• MDR Text Key: 286234121
• Report Number: 9611451-2021-01442
• Device Sequence Number: 1
• Product Code: BZE
• UDI-Device Identifier: 09420012431103
• UDI-Public: (01)09420012431103(10)2101744312(11)210805
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• 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: 2101744312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2021
• 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
• Treatment: SERVO I VENTILATOR; SERVO I VENTILATOR