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

Model Number RT266

Device Problem Leak/Splash (1354)

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

Event Date 11/15/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A healthcare facility in california reported via a fisher & paykel healthcare (f&p) field representative that a rt266 infant dual heated evaqua2 breathing circuit was leaking during patient use from the connection of the dryline and the inspiratory filter.There was no patient consequence.

Manufacturer Narrative

(b)(4).Method: the complaint rt266 infant dual-heated evaqua2 breathing circuit was returned to fisher & paykel healthcare (f&p) in new zealand, where it was visually inspected and leak tested.Results: visual inspection of the complaint rt266 infant dual-heated evaqua2 breathing circuit revealed no damage was found to the dryline.The dryline port cap was observed not fully inserted into the port.The leakage 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.However, the leak the customer experienced was most likely due to the dryline port not fully closed.All rt266 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 rt266 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." - "ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient.".

Event Description

A healthcare facility in california reported via a fisher & paykel healthcare (f&p) field representative that a rt266 infant dual heated evaqua2 breathing circuit was leaking during patient use from the connection of the dryline and the inspiratory filter.There was no patient consequence.

• 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: 15966102
• MDR Text Key: 305510435
• Report Number: 9611451-2022-01175
• 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: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• 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: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 04/18/2023
• 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