MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT; BZE

Model Number RT265

Device Problem Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/14/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in the process of obtaining the complaint rt265 infant dual heated evaqua2 breathing circuit from the healthcare facility.We will provide a follow-up report once we have received the complaint device and completed our investigation.

Event Description

A healthcare facility in (b)(6) reported to a fisher & paykel healthcare (fph) field representative that excessive condensation occurred in the inspiratory limb of an rt265 infant dual heated evaqua2 breathing circuit, which allegedly led to oxygen desaturation of the patient.No medical or surgical intervention was reported as a result of this incident.Following the incident, the fph representative visited the hospital and learned that the patient was extubated but still on cpap therapy.

Manufacturer Narrative

(b)(4).Method: the subject breathing circuit was returned to fisher & paykel healthcare (b)(4) for investigation.The subject breathing circuit was visually inspected.The inspiratory and expiratory heater wires of the subject breathing circuit were resistance tested.Results: visual inspection revealed that there was no damage found to the subject breathing circuit.Resistance testing revealed that both the inspiratory and expiratory heater wire resistance was within specification.A lot check revealed no other complaints of this nature for the lot number provided.Condensate in the humidification system, although not preferred, is an expected side effect of heated pass-over humidification systems in many conditions, and may vary between light misting to water droplets that form on the wall of the cool breathing circuit tubing.The amount of condensate in the ventilation system is influenced by a number of multiple setup and environmental factors.The customer reported the use of the unheated extension in an open incubator.It is possible that the use of the unheated extension outside of the incubator has contributed to the condensation issues that the customer experienced.The user instructions that accompany the rt265 infant dual heated evaqua2 breathing circuit state the following: check breathing circuits for condensation every 6 hours and drain if required.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 healthcare facility in (b)(6) reported to a fisher & paykel healthcare (fph) field representative that excessive condensation occurred in the inspiratory limb of an rt265 infant dual heated evaqua2 breathing circuit, which allegedly led to oxygen desaturation of the patient.No medical or surgical intervention was reported as a result of this incident.Following the incident, the fph representative visited the hospital and learned that the patient was extubated but still on cpap therapy.

• Brand Name: INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
• Type of Device: BZE
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer Contact: raymond yan ; 15365 barranca parkway; irvine; 9494534000
• MDR Report Key: 5429107
• MDR Text Key: 37984305
• Report Number: 9611451-2016-00042
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K103767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/14/2016

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: RT265
• Device Catalogue Number: RT265
• Device Lot Number: 150515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/14/2016
• Initial Date FDA Received: 02/10/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2015
• 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