MAUDE Adverse Event Report: ADULT ANAESTHESIA CIRCUIT; BTT

Model Number RT109

Device Problem Disconnection (1171)

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

Event Date 10/22/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.The complaint rt109 adult anaesthesia circuit was received at fisher & paykel healthcare (f&p) in (b)(4).We are currently in the process of our investigation.We will provide a follow up report upon completion of completing our investigation.

Event Description

A distributor in (b)(4) reported that the connection between the y-piece and a rt109 adult anaesthesia circuit disconnected after one day of use.There was no reported patient consequence.

Event Description

A distributor in japan reported that the connection between the y-piece and a rt109 adult anaesthesia circuit disconnected after one day of use.There was no reported patient consequence.

Manufacturer Narrative

(b)(4).Correction to section h10 results.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 the breathing circuit limbs were found loose at the y-piece.No damage was observed to the y-piece connector or the tube cuffs however white residue was found on the limbs near the y piece.The tubing was reconnected to the distal connector and it was found that a tight connection was able to be achieved.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.".

Event Description

A distributor in japan reported that the connection between the y-piece and a rt109 adult anaesthesia circuit disconnected after one day of use.There was no reported patient consequence.

Manufacturer Narrative

(b)(6).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 complaint circuit revealed that one of the limbs was found loose at the y-piece end and no damage to the y-piece or the tube cuffs.A tight connection between the tube and the y-piece connector was found.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: 10912793
• MDR Text Key: 219139591
• Report Number: 9611451-2020-01057
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2020
• 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: 11/23/2020
• Date Manufacturer Received: 01/19/2021
• 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