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

Model Number RT380

Device Problems Break (1069); Crack (1135)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in the process of finalising our investigation.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in ireland reported that the expiratory tubing of ten rt380 adult dual heated evaqua2 breathing circuits would develop cracks during use.There was no reported patient consequence.

Event Description

A healthcare facility in ireland reported that the expiratory tubing of ten rt380 adult dual heated evaqua2 breathing circuits would develop cracks during use.There was no reported patient consequence.

Manufacturer Narrative

(b)(6).Method: the complaint rt380 evaqua2 adult breathing circuits were returned to fisher & paykel healthcare (f&p) in new zealand for evaluation, where it was visually inspected and analysed.Results: visual inspection of the returned circuits revealed that the expiratory tube of a rt380 adult dual heated evaqua2 breathing circuits were degraded.Ftir testing revealed that the tubing had been exposed to chemicals that induced hydrolysis and degradation.Conclusion: we are unable to determine the cause of the reported event.However, based on our investigation, it is likely due to chemical exposure to the expiratory tube.All rt380 adult evaqua2 breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The subject adult breathing circuits would have met the required specifications at the time of production.Our user instructions that accompany the rt380 adult evaqua2 breathing circuit state the following: - "do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers." - "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient." - "ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient.".

• Brand Name: ADULT 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: 14824882
• MDR Text Key: 298491734
• Report Number: 9611451-2022-00520
• Device Sequence Number: 1
• Product Code: BZE
• UDI-Device Identifier: 09420012429728
• UDI-Public: (01)09420012429728(10)2101424405(11)201207
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K122432
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT380
• Device Catalogue Number: RT380
• Device Lot Number: 2101424405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2022
• Date Manufacturer Received: 07/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2020
• 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: AVEA & DRÄGER VENTILATOR CIRCUIT HANGERS.