MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED ADULT INSPIRATORY HEATED BREATHING CIRCUIT; BTT

Model Number RT105

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 08/07/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in the process of completing our investigation.We will provide a follow up report upon completion of our investigation.

Event Description

A distributor reported on behalf of a healthcare facility in (b)(6), via a fisher and paykel healthcare (f&p) field representative, that four rt105 adult breathing circuits did not pass the ventilator leak test during set-up and were found leaking from the water trap.There was no patient involvement.

Event Description

A distributor reported on behalf of a healthcare facility in japan, via a fisher and paykel healthcare (f&p) field representative, that four rt105 adult breathing circuits did not pass the ventilator leak test during set-up and were found leaking from the water trap.There was no patient involvement.

Manufacturer Narrative

(b)(4).Method: the three of the four complaint (b)(4) adult breathing circuits were returned to fisher & paykel healthcare in (b)(6) where they were visually inspected and pressure tested.Results: pressure testing revealed that one of the three complaint circuits was out of specification.The water bath test revealed that the leak was through the connection between the lid and bowl of the water trap.Visual inspection revealed that the sealing edge of the bowl was found deformed.Conclusion: we are unable to determine what caused the damage to the water trap of the breathing circuit.However based on the information provided, it is possible that the damage was caused when the caregiver opened the watertrap before use.The water trap of the breathing circuit consists of two parts, a lid and a bowl, which can be separated to allow the caregiver to empty the water trap.All breathing circuits are pressure tested for leaks during production and those that fail are rejected.This suggests that any leak must have developed after the breathing circuit was released for distribution, during transport, storage or use, possibly by distortion of the water trap when the bowl was connected.The user instructions that accompany the rt105 adult breathing circuit state the following: 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.Set appropriate ventilator alarms.

• Brand Name: ADULT INSPIRATORY HEATED BREATHING CIRCUIT
• Type of Device: BTT
• 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: 12436052
• MDR Text Key: 271650958
• Report Number: 9611451-2021-01005
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012430427
• UDI-Public: (01)09420012430427(10)2101370036(11)201103
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT105
• Device Catalogue Number: RT105
• Device Lot Number: 2101370036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/09/2021
• Initial Date FDA Received: 09/07/2021
• Supplement Dates Manufacturer Received: 11/08/2021
• Supplement Dates FDA Received: 11/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2020
• 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
• Treatment: HUMIDIFIER: MR850GJU; HUMIDIFIER: MR850GJU; VENTILATOR: PB840; VENTILATOR: PB840