MAUDE Adverse Event Report: ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT; BZE

Model Number RT380

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/05/2020

Event Type  malfunction  

Manufacturer Narrative

Ps342105.The complaint rt380 adult evaqua2 breathing circuit is currently en route to fisher & paykel healthcare (f&p) in (b)(6) for evaluation.We will provide a follow-up report upon completion of investigation.

Event Description

A distributor on behalf of a healthcare facility in (b)(6) reported, via a fisher & paykel healthcare (f&p) field representative, that a rt380 adult dual-heated evaqua2 breathing circuit was found to be leaking water.There was no reported patient consequences.

Manufacturer Narrative

(b)(4).Method: the complaint rt380 evaqua 2 adult breathing circuit was returned to fisher & paykel healthcare (f&p) in new zealand, where it was visually inspected.Results: visual inspection of the returned breathing circuit revealed that the tubing has a hole was found about 10cm from the patient end connector.Conclusion: the damage observed was most likely due to puncture by a blunt object.All rt380 adult evaqua2 breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The subject infant breathing circuits 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: perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.Set appropriate ventilator alarms.

Event Description

A distributor on behalf of a healthcare facility in japan reported, via a fisher & paykel healthcare (f&p) field representative, that a rt380 adult dual-heated evaqua2 breathing circuit was found to be leaking water.There was no reported patient consequences.

• Brand Name: ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
• Type of Device: BZE
• MDR Report Key: 10228473
• MDR Text Key: 204040682
• Report Number: 9611451-2020-00604
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• PMA/PMN Number: K103767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 06/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2020
• 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: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2020
• Date Manufacturer Received: 07/08/2020
• 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