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 Date 07/11/2022

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 distributor reported on behalf of a healthcare facility in japan via a fisher & paykel healthcare (f&p) field representative that the y-piece of the expiratory limb of a rt380 adult dual heated evaqua2 breathing circuit was found cracked during patient use.There was no patient consequence.

Manufacturer Narrative

(b)(4).Method: the complaint rt380 adult dual heated evaqua2 breathing circuit was returned to fisher & paykel healthcare (f&p) in new zealand for investigation, where it was visually inspected and analysed.Results: visual inspection identified a crack on the collar of the patient end of the expiratory limb.Further testing reveals environmental stress cracking due to chemical exposure on the collar.Conclusion: we are unable to determine the cause of the reported event.However, based on our investigation, it is likely due to exposure to chemicals causing environmental stress cracking.All rt380 adult dual-heated evaqua2 breathing circuits are visually inspected, and pressure and flow tested during production, and those that fail are rejected.The subject breathing circuit would have met the required specifications at the time of production.Our user instructions that accompany the rt380 adult evaqua2 breathing circuit show in pictorial format the correct set-up of the circuit and also states the following: - "check all connections are tight before use." - "ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient." - "do not soak, wash or sterilize this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers.".

Event Description

A distributor reported on behalf of a healthcare facility in japan via a fisher & paykel healthcare (f&p) field representative that the y-piece of the expiratory limb of a rt380 adult dual heated evaqua2 breathing circuit was found cracked during patient use.There was no patient consequence.

• 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 drive; suite 300; irvine, CA 92618 ; 9494534000
• MDR Report Key: 15188519
• MDR Text Key: 297588056
• Report Number: 9611451-2022-00716
• Device Sequence Number: 1
• Product Code: BZE
• UDI-Device Identifier: 09420012429728
• UDI-Public: (01)09420012429728(10)2102012359(11)220202
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K122432
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2022
• 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: 2102012359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2022
• 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