MAUDE Adverse Event Report: ADULT ANAESTHESIA CIRCUIT; BTT

Model Number RT109

Device Problems Disconnection (1171); Detachment of Device or Device Component (2907)

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

Event Date 01/18/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint rt109 adult anaesthesia circuit has arrived at fisher & paykel healthcare(f&p) (b)(4) for evaluation.We will provide a follow up report upon completion of our investigation.

Event Description

A distributor in (b)(6) reported on behalf of a healthcare facility that the connection between the y-piece and a rt109 adult anaesthesia circuit disconnected during set up.There was no patient involvement.

Event Description

A distributor in japan reported on behalf of a healthcare facility that the connection between the y-piece and a rt109 adult anaesthesia circuit disconnected during set up.There was no patient involvement.

Manufacturer Narrative

(b)(4).Section g4: this product is not sold in the usa however it is similar to a product which is sold in the usa.The 510(k) for the similar product is k983112.Method: the complaint rt109 adult anaesthesia circuit was returned to fisher & paykel healthcare (f&p) in new zealand for investigation where they were visually inspected.Results: visual inspection of the returned device revealed that one of the breathing circuit limbs was found loose at the y-piece.No damage was observed to the y-piece connector or the tube cuffs.A tight connection between the tube and the connector was found at the connector end of both limbs.Conclusion: we were unable to determine what may have caused the reported event.All rt109 adult anaesthesia circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The subject circuit would have met the required specifications at the time of production.Our user instructions that accompany the rt109 adult anaesthesia circuits state the following: - "visually inspect breathing sets for damage (e.G.A crushed tube or cracked connector) before use and replace if damaged." - "check all connections are tight before use." - "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.".

• Brand Name: ADULT ANAESTHESIA CIRCUIT
• Type of Device: BTT
• MDR Report Key: 11381367
• MDR Text Key: 244875190
• Report Number: 9611451-2021-00178
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Type of Report: Initial,Followup
• Report Date: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT109
• Device Catalogue Number: RT109
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Date Manufacturer Received: 04/30/2021
• 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