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

Model Number RT380

Device Problems Break (1069); Gas/Air Leak (2946)

Patient Problems Low Oxygen Saturation (2477); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2022

Event Type  malfunction  

Event Description

A healthcare facility in (b)(6) reported a rt380 adult dual heated evaqua2 breathing circuit leaked during patient use.The issue was found soon after set up.It was reported that an alarm sounded indicating a circuit leak.The healthcare facility reported that the patient experienced increased heart rate at 120/min and had desaturated from 93mmhg to 74mmhg.In response, the patient was manually ventilated with a bag-valve mask while the circuit was replaced.The location of the air leakage was found to be at the inspiratory tube connection port to the mr290 vented autofeed humdification chamber.It was further noted that blood analysis was checked again half an hour after the reported event, and results were within normal range.No further patient consequences were reported.

Manufacturer Narrative

(b)(4).We are currently in the process of finalising our investigation.We will provide a follow up report upon completion of investigation.

Manufacturer Narrative

(b)(4).Corrections: further information was received from the healthcare facility after the submission of the initial report.This confirmed that the reported event occurred prior to patient use and there was therefore no patient involvement or consequence.Section a2/b7 - removed as there was no patient involved.Section h6 (health effect codes) - updated to 4582 - no clinical signs, symptoms or conditions, 2645 - no patient involvement.Section b5 - narration corrected based off additional information.Method: the complaint rt380 adult dual heated evaqua2 breathing circuit was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is therefore based on the information and photograph provided by the customer, and our knowledge of the product.Results: visual inspection of the provided photograph identified damage to the inspiratory tube near the elbow connector.Conclusion: without the return of the complaint device, we are unable to determine the cause of the reported event.All rt380 adult evaqua2 breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The subject adult breathing circuit would have met the required specifications at the time of production.Our user instructions that accompany the rt380 adult evaqua2 breathing circuit state the following: - "do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers." - "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 china reported a rt380 adult dual heated evaqua2 breathing circuit failed the pre-use leak test.Inspection of the circuit identified damage to the inspiratory tube.There was no patient involvement as the event occurred prior to patient use.

• 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 road; suite 300; irvine, CA 92618 ; 9494534000
• MDR Report Key: 15557949
• MDR Text Key: 301520912
• Report Number: 9611451-2022-00920
• Device Sequence Number: 1
• Product Code: BZE
• UDI-Device Identifier: 09420012429728
• UDI-Public: (01)09420012429728(10)2101751688(11)210806
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K122432
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2022
• 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: 2101751688
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2021
• 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: EVITA V300 VENTILATOR; EVITA V300 VENTILATOR; F&P MR290 VENTED AUTOFEED HUMIDIFICATION CHAMBER; F&P MR290 VENTED AUTOFEED HUMIDIFICATION CHAMBER
• Patient Age: 59 YR