MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD ADULT ANAESTHESIA CIRCUIT; BTT

Model Number RT109

Device Problem Disconnection (1171)

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

Event Date 08/17/2023

Event Type  malfunction  

Event Description

A distributor reported on behalf of a healthcare facility in japan, that the connection between the y-piece and tubing of five rt109 adult anaesthesia circuits disconnected before patient use.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.The complaint rt109 adult anaesthesia circuit is currently en route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow up report upon completion of investigation.

Manufacturer Narrative

(b)(4).Corrected data: section b5.Describe event or problem: a distributor reported on behalf of a heathcare facility in japan, that the connection between the y-piece and tubing of six rt109 adult anaesthesia circuits disconnected before patient use.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 five complaint rt109 adult anaesthesia circuits were returned to fisher & paykel healthcare (f&p) in new zealand where they were visually inspected and analyzed.Results: visual inspection of returned circuits observed that the tubings were found detached from y-piece.Physical examination showed that the connectors were easily removed, which strongly indicate that the circuits have been through a thermal disinfection cycle.Further analysis showed faint signs of an unknown residue.Thermal disinfection, e.G.Pasteurization or autowasher cleaning, will cause stress relaxation in tube material resulting in the tube cuff expanding and becoming loose on the connectors.As this was clearly observed, and the surface residues were extremely low concentration, it is reasonable to conclude that the part has most likely been subject to a cleaning cycle.Conclusion: we were unable to determine what may have caused the reported failure mode at this stage.However based on our investigation, the complaint devices were most likely been subject to a cleaning cycle.All rt109 adult anaesthesia circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The subject breathing circuit would have met the required specifications at the time of production.The user instructions that accompany the rt109 adult anaesthesia circuit state the following: - "do not reuse this product.Reuse may result in transmission of infectious substances, interruption to treatment, serious harm or death." - "do not use beyond 7 days maximum duration of use." - "do not soak, wash, or sterilize this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers." - "visually inspect breathing sets for damage before use and replace if damaged." - "ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient." - "perform a pressure and leak test on the breathing system and check for occlusions before connection to a patient." - "check all connections are tight before use.".

Event Description

A distributor reported on behalf of a heathcare facility in japan, that the connection between the y-piece and tubing of six rt109 adult anaesthesia circuits disconnected before patient use.There was no patient involvement.

• Brand Name: ADULT ANAESTHESIA CIRCUIT
• Type of Device: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: omid taheri ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 8007923912
• MDR Report Key: 17726521
• MDR Text Key: 323182253
• Report Number: 9611451-2023-00850
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2023
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/01/2023
• 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