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

Model Number RT380

Device Problem Material Puncture/Hole (1504)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/25/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are in the process of completing our investigation.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 has a hole.There was no patient involvement.

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 has a hole.There was no patient involvement.

Manufacturer Narrative

(b)(4).Method: the complaint rt380 evaqua 2 adult breathing circuit was returned to fisher & paykel healthcare (f&p) for evaluation, where it was visually inspected and pressure tested.Our investigation is based on the information provided by the customer and our investigation of the returned device.Results: visual inspection of the returned complaint circuit was observed to have a small hole in the inspiratory limb.A pressure test revealed that the breathing circuit was out of specification.It was reported by the hospital that the circuit passed the ventilator leak test prior to set-up.Conclusion: we are unable to conclusively determine the cause of the breathing circuit to be out of specification.However, based on the information provided by the customer and our investigation, this likely occured during transport.All rt380 are designed to conform to iso:5367.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 reuse may result in transmission of infectious substances, interruption to treatment, serious harm or death.Perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.Set appropriate ventilator alarms.

• Brand Name: ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
• Type of Device: BZE
• MDR Report Key: 10584725
• MDR Text Key: 212149920
• Report Number: 9611451-2020-00801
• Device Sequence Number: 1
• Product Code: BZE
• UDI-Device Identifier: 09420012429728
• UDI-Public: 010942001242972810210108027611200421
• 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: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• 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: 2101080276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2020
• Date Manufacturer Received: 10/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2020
• 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