MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD INFANT BIAS FLOW BREATHING CIRCUIT; BTT

Model Number RT225

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4) method: the complaint rt225 infant bias flow breathing circuit was returned to fph in (b)(4).The circuit was visually inspected and the tightness of the connection was checked.Results: visual inspection revealed that there was no physical damage to the expiratory tube or the patient end connector.The connection check revealed that the connection between the tube and connector was loose and able to be disconnected easily.Conclusion: we could not determine why the connector and tubing became loose during use.The expiratory tube and patient end connector are assembled using a machine to ensure a consistent tightness of connection.The quality of the connection is visually checked.Any that are not inserted correctly are wasted.The connection is then 100% pressure leak and flow tested as part of the infant breathing circuit before leaving the production line.Any breathing circuits that fail these tests are rejected.The subject rt225 infant breathing circuit would have met the required specification at the time of production.The user instructions that accompany the rt225 infant bias flow 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.".

Event Description

A hospital in (b)(6) reported via a fisher and paykel healthcare (fph) field representative that the connector on the expiratory limb of an rt225 infant bias flow breathing circuit came loose during set up.This was found prior to patient use.

• Brand Name: INFANT BIAS FLOW BREATHING 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; 2013 ; NZ 2013
• Manufacturer Contact: sharon kuruvilla ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 7262678
• MDR Text Key: 100048938
• Report Number: 9611451-2018-00106
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012431080
• UDI-Public: 010942001243108010
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K020332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT225
• Device Catalogue Number: RT225
• Device Lot Number: 2100268329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2017
• 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