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

Model Number RT380

Device Problems Misconnection (1399); Use of Device Problem (1670); Connection Problem (2900)

Patient Problem Low Oxygen Saturation (2477)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint rt380 adult 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 healthcare facility in (b)(6) reported that the inspiratory and expiratory limbs of a rt380 adult dual-heated evaqua2 breathing circuit were incorrectly connected in reverse on a patient.It was further reported that the customer did not use the water chamber.The patient experienced desaturation and was reintubated.The patient recovered to a stable condition after the set-up was corrected.There were no further patient consequences.

Event Description

A healthcare facility in alabama reported that the inspiratory and expiratory limbs of a rt380 adult dual-heated evaqua2 breathing circuit were incorrectly connected in reverse on a patient.It was further reported that the customer did not use the water chamber.The patient experienced desaturation and was reintubated.The patient recovered to a stable condition after the set-up was corrected.There were no further patient consequences.

Manufacturer Narrative

(b)(4).Corrected data: section d9 device available for evaluation? no.Section h3 device evaluated by manufacturer? other.Method: the complaint rt380 adult dual-heated evaqua2 breathing circuit was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the information provided by the customer and our knowledge of the product.Results: the customer reported that the inspiratory and expiratory limbs of a rt380 adult dual-heated evaqua2 breathing circuit were incorrectly connected in reverse on a patient.It was further reported that the customer did not use the water chamber.The patient experienced desaturation and was reintubated.The patient recovered to a stable condition after the set-up was corrected.Conclusion: the reported reversed connection of the inspiratory dryline and expiratory limb at the ventilator end was due to a user error.In this instance, the patient continued to receive gas flow, however no humidity was provided.The mr850 respiratory humidifer complies with the gas connection ports specified in the current ventilator standard iso 80601-2-12:2020 (particular requirements for basic safety essential performance of critical care ventilators).This standard specifies both gas connection ports to be 22 mm,15mm or 11.5mm male taper connections which comply with iso 5356-1:2015 (breathing circuit conical connectors).Due to this, the prevention of reversed connections is highly dependent upon the user.The user instructions that accompany the rt380 adult dual-heated evaqua2 breathing circuit show in pictorial format the correct set-up of the system, including arrows indicating the flow of gas via the inspiratory limb from the ventilator, through the humidifier, to the patient and returned to the ventilator via the expiratory limb.The user instructions also include the following warnings and cautions: - "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" - "ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient" - "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a 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 ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 13311481
• MDR Text Key: 286361479
• Report Number: 9611451-2022-00017
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2022
• 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: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2022
• 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