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

Model Number RT380

Device Problem Device Handling Problem (3265)

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

Event Date 08/30/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the three complaint rt380 adult evaqua2 breathing circuit kits were returned to fisher & paykel healthcare (f&p) in (b)(4) for investigation.These devices were visually inspected.Results: during initial reporting of the complaint, it was reported that the nurse may have tried to connect the nebulizer to the wrong position on the rt380 circuit.Visual inspection revealed that the inspiratory limbs of all three units that were returned had the elbow and the patient end connector loose.Conclusion: we were unable to determine conclusively the cause of the reported event.However, based on previous complaints it is possible that the circuits were cleaned and reused which could lead to the reported event.Rt380 breathing circuits are visually inspected and pressure tested for leaks before releasing for distribution.Any breathing circuit which fails any of these tests is discarded.If any faults are detected the whole batch is placed on hold for investigation.The user instructions that accompany the rt380 breathing circuit state the following: check all connections are tight before use.Set appropriate ventilator alarms.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.

Event Description

A distributor in (b)(6) reported on behalf of a healthcare facility that three rt380 adult dual heated evaqua2 breathing circuits were found to have rotatable patient side connectors.It was also reported that the nurse used the nebulizer from the wrong position as the inspiratory limb of the breathing circuit was disconnected from the connector.There was no reported patient consequence.

• Brand Name: ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
• Type of Device: BZE
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 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: 9236178
• MDR Text Key: 178339605
• Report Number: 9611451-2019-01014
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K122432
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2019
• 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: 10/14/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2019
• 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