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

Model Number RT265

Device Problems Crack (1135); Degraded (1153); Material Discolored (1170)

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

Event Date 05/13/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).One of the two complaint rt265 infant dual-heated evaqua2 breathing circuits is currently en route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative, that two rt265 infant dual-heated evaqua2 breathing circuits were cracked before use.It was further reported that the circuits were stored in an area exposed to heat.There was no patient involvement.

Event Description

A healthcare facility in tennessee reported via a fisher & paykel healthcare (f&p) field representative, that two rt265 infant dual-heated evaqua2 breathing circuits were cracked before use.It was further reported that the circuits were stored in an area exposed to heat.There was no patient involvement.

Manufacturer Narrative

(b)(4).Method: 1) one of the complaint two complaint rt265 infant dual heated evaqua2 breathing circuit was not returned to fisher & paykel healthcare (f&p) for investigation.Our investigation is thus based on the photos provided by the customer, previous investigations of similar complaints and our knowledge of the product.2)the other complaint rt265 infant dual-heated evaqua2 breathing circuit was returned to fisher & paykel healthcare (f&p) in new zealand for investigation, where it was visually inspected.Results: 1) visual inspection of the provided photos revealed that the evaqua 2 limb was cracked and degraded.2)visual inspection of the returned device revealed that the evaqua 2 limb was discolored while there was no damage to the device.Conclusion: 1) we are unable to determine was caused the reported event.However, it is known that this can be due to the tube being in contact with chemicals or being exposed to uv light for a long period of time.2)we are unable to determine was caused the reported event.All rt265 infant dual heated evaqua2 breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.Our user instructions that accompany the rt265 infant dual heated evaqua2 breathing circuit 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.".- "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: 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 ; 9494534002
• MDR Report Key: 12236820
• MDR Text Key: 265804114
• Report Number: 9611451-2021-00878
• Device Sequence Number: 1
• Product Code: BZE
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT265
• Device Catalogue Number: RT265
• Device Lot Number: NOT PROVIDED
• 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
• 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