MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED INFANT CONTINUOUS FLOW BREATHING CIRCUIT; BTT

Model Number RT330

Device Problems Material Separation (1562); Moisture or Humidity Problem (2986)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/02/2014

Event Type  malfunction  

Event Description

A medical centre in (b)(6) reported to a fisher & paykel healthcare (fph) representative that they noticed excessive condensation in the rt330 infant optiflow circuit during use.The medical centre also reported that the inner tubing had separated from the outer tubing near the chamber end.No patient consequence reported.

Manufacturer Narrative

(b)(4).Method: the complaint device was not returned to fisher & paykel healthcare in (b)(6.Therefore, our investigation is based on the information provided by the hospital, previous investigations of similar complaints and our knowledge of the product.A lot check could not be peformed as a lot number was not provided.Without the return of the complaint device we are unable to determine what may have caused the problem experienced by the customer.However, it is possible that the observed condensate was influenced by environmental conditions, such as the ambient temperature.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 cool breathing circuit tubing.The amount of condensate in the optiflow system is influenced by a number of multiple set up and environmental factors.If the complaint breathing circuit had been returned to fisher & paykel healthcare, the resistance of the heater wire would have been measured and the breathing circuit would have been connected to an opt312 optiflow junior interface and performance tested.Also, the circuit would have been visually inspected for the reported fault of the inner tubing becoming separated from the outer tubing near the chamber end.The user instructions supplied with the rt330 infant optiflow circuit state the following: - "patient monitoring is recommended." - "do not cover the circuit with material such as blankets, towels or bed linen." - "do not stretch or milk the tubing." device not returned to manufacturer.

• Brand Name: INFANT CONTINUOUS FLOW BREATHING CIRCUIT
• Type of Device: BTT
• 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, CA 92618-2216
• MDR Report Key: 3607191
• MDR Text Key: 4090881
• Report Number: 9611451-2014-00099
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT330
• Device Catalogue Number: RT330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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