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

Model Number RT380

Device Problems Detachment of Device or Device Component (2907); Device Handling Problem (3265)

Patient Problem No Patient Involvement (2645)

Event Date 12/14/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint rt380 breathing circuit is currently en route to fisher & paykel healthcare (b)(4) for evaluation.We are in process to determine if f&p's product caused or contributed to the reported event.We will provide a follow up report upon completion of our investigation.

Event Description

A hospital in (b)(6) reported via a distributor that the "inspiratory limb came out from the chamber elbow connector" of an rt380 adult dual heated evaqua2 breathing circuit.There was no patient consequence reported.

Event Description

A hospital in japan reported via a distributor that the "inspiratory limb came out from the chamber elbow connector" of an rt380 adult dual heated evaqua2 breathing circuit.There was no patient consequence reported.

Manufacturer Narrative

(b)(4).Method: the inspiratory circuit of the complaint rt380 evaqua2 breathing circuit was returned to fisher & paykel healthcare new zealand and was visually inspected.Result: the visual inspection revealed that the inspiratory limb was returned with the elbow and patient end connector loose.Conclusion: we were unable to determine conclusively the cause of the reported event.However, it is possible that the circuit was cleaned and reused which could lead to the reported event.All 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.This suggests that the damage occurred after the product was released for distribution, during transportation or storage.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.

• 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: 8224976
• MDR Text Key: 132543274
• Report Number: 9611451-2019-00007
• 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: 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2019
• 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: 01/25/2019
• Date Manufacturer Received: 12/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1