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

Model Number RT380

Device Problem Disconnection (1171)

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

Event Date 10/27/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint rt380 adult dual-heated evaqua2 breathing circuit along with its mr290v vented auto-filled humidification chamber was returned to fisher & paykel healthcare (f&p) in (b)(6) for evaluation, where it was visually inspected and tested.Results: visual inspection revealed that no damage was found to the mr290 ports or the dryline connectors.Both chamber ports formed a tight connection with the dryline connectors.Conclusion: the disconnection was most likely due to the customer not connecting the dryline correctly.The customer further reported that the dry line was likely pulled by the nurse.All rt380 adult dual-heated evaqua2 breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The user instructions that accompany the rt380 adult dual-heated evaqua2 breathing circuit state: "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." "check all connections are tight.".

Event Description

A distributor in (b)(4) reported on behalf of a healthcare facility, via a fisher & paykel healthcare (f&p) field representative, that the dryline of a rt380 adult dual-heated evaqua 2 breathing circuit was found disconnected from the f&p mr290v vented auto-filled humidification chamber during use.There was no patient consequences.

• 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
• MDR Report Key: 10912750
• MDR Text Key: 218688939
• Report Number: 9611451-2020-01085
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• PMA/PMN Number: K122432
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2020
• 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: 2100997420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Date Manufacturer Received: 10/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2020
• 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