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

Model Number RT265

Device Problem Moisture or Humidity Problem (2986)

Patient Problem Low Oxygen Saturation (2477)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Further information regarding the reported event has been requested from the healthcare facility.The complaint rt265 infant dual heated evaqua2 breathing circuit 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 distributor reported on behalf of a healthcare facility in california via a fisher & paykel healthcare (f&p) representative that an intubated patient had desaturated to 80% spo2 while connected to an rt265 infant dual-heated evaqua2 breathing circuit in which the "line filled with water" and reported that there appeared to be more condensation than usual.A photograph of the set-up provided by the healthcare facility showed the use of an aerogen nebulizer at the inlet port of the mr290 vented autofeed humidification chamber.There was no further patient consequence reported.

Manufacturer Narrative

(b)(4).Method: the complaint rt265 infant dual-heated evaqua2 breathing circuit was requested from the healthcare facility; however, it was not returned to fisher & paykel healthcare (f&p) for evaluation.The f&p field representative also contacted the healthcare facility to request further information regarding the reported event however, no further information was made available.Our investigation is therefore based on the information and photograph provided by the healthcare facility, and our knowledge of the product.Results: the healthcare facility reported that an intubated patient had desaturated to 80% spo2 while connected to an rt265 infant dual-heated evaqua2 breathing circuit in which the "line filled with water" and reported that there appeared to be more condensation than usual.The photograph provided by the healthcare facility demonstrated that the unheated breathing tube extension provided with the rt265 breathing circuit kit was attached to the heated breathing tube.A large proportion of the unheated breathing tube appeared to be outside the incubator.Conclusion: without the complaint device, we are unable to determine what may have caused the reported event.Condensate in the humidification system, although not preferred, is an expected side effect of heated pass-over humidification systems in many conditions, and may vary between light misting to water droplets that form on the wall of cool breathing circuit tubing.The amount of condensate in the ventilation system is influenced by a number of multiple setup and environmental factors.The use of an unheated breathing tube extension outside of the incubator may have contributed to the excessive condensation reported by the healthcare facility, the temperature change between the heated and unheated breathing tube would contribute to condensation.All rt265 infant 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.The user instructions that accompany the rt265 infant dual-heated evaqua2 breathing circuit include a pictorial showing the correct setup to connect the unheated extension while the patient is in an incubator or infant warmer.It also includes the following: "appropriate patient monitoring (e.G.Oxygen saturation) must be used at all times.Failure to monitor the patient (e.G.In the event of an interruption to gas flow) may result in serious harm or death." "when mounting a humidifier adjacent to a patient ensure that the humidifier is always positioned lower than the patient." "do not cover the circuit with material such as blankets, towels or bed linen." "ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient." "check breathing circuits for condensation every 6 hours and drain if required." "check that the heater wire is evenly distributed along the circuit and not bunched or kinked.".

Event Description

A distributor reported on behalf of a healthcare facility in california via a fisher & paykel healthcare (f&p) representative that an intubated patient had desaturated to 80% spo2 while connected to an rt265 infant dual-heated evaqua2 breathing circuit in which the "line filled with water" and reported that there appeared to be more condensation than usual.A photograph of the set-up provided by the healthcare facility showed the use of an aerogen nebulizer at the inlet port of the mr290 vented autofeed humidification chamber.There was no further patient consequence reported.

• 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: 15902585
• MDR Text Key: 304684216
• Report Number: 9611451-2022-01103
• 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,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RT265
• Device Catalogue Number: RT265
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: AEROGEN NEBULIZER.; AEROGEN NEBULIZER.; AVEA VENTILATOR.; AVEA VENTILATOR.; F&P MR290 VENTED AUTOFEED HUMIDIFICATION CHAMBER.; F&P MR290 VENTED AUTOFEED HUMIDIFICATION CHAMBER.
• Patient Outcome(s): Other
• Patient Age: 2 MO