MAUDE Adverse Event Report: OPTIFLOW JUNIOR TUBING KIT; BTT

Model Number RT330

Device Problems Device Displays Incorrect Message (2591); Sparking (2595)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint rt330 infant optiflow circuit is currently en-route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow up report upon completion of investigation.

Event Description

A healthcare facility in florida reported via a fisher & paykel healthcare (f&p) field representative, that a rt330 infant optiflow circuit had a flash and spark at the proximal connection.The mr850 respiratory humidifier alarmed and stopped heating.There was no reported patient consequences.

Event Description

A healthcare facility in florida reported via a fisher & paykel healthcare (f&p) field representative, that a rt330 infant optiflow circuit had a flash and spark at the proximal connection.The mr850 respiratory humidifier alarmed and stopped heating.There was no reported patient consequences.

Manufacturer Narrative

(b)(4).Method: the complaint rt330 optiflow junior tubing was returned to fisher & paykel healthcare (f&p) in new zealand where it was visually inspected and tested.Results: visual inspection of the connection between the heater wire and the heater wire pin at the distal end of the rt330 breathing circuit observed that the heater wire insulation was discoloured.Testing of the heater wire revealed that the heater wire resistance was outside of the specification.Conclusions: based on the findings of the returned complaint device, the reported event occurred on the heater wire connection inside the overmoulded heater wire plug at the distal end of the rt330 breathing circuit.The observed discolouration of the insulation on the wire is characteristic of exposure to heat.We are unable to determine the source of the exposure to heat.It should be noted that the mr850 respiratory humdifier alarmed to notify the user.All breathing circuits are visually inspected and pressure tested during production.In addition, a resistance test is performed on the inserted heater wires and those that fails, are rejected.The subject rt330 circuit would have met the required specification at the time of production.Our user instructions that accompany the rt330 optiflow junior tubing kit state the following: do not stretch or milk the tubing.Do not soak, wash, sterilise or re-use this product.Avoid contact with chemicals, cleaning agents or hand sanitizers.Appropriate patient monitoring must be used at all times.Ensure appropriate ventilatory or flow source alarms are set before connecting breathing set to patient.

• Brand Name: OPTIFLOW JUNIOR TUBING KIT
• Type of Device: BTT
• MDR Report Key: 11174738
• MDR Text Key: 228184011
• Report Number: 9611451-2021-00049
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K122432
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• 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
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Date Manufacturer Received: 06/09/2021
• 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
• Treatment: F&P 900MR805 HEATER WIRE ADAPTOR; F&P MR850 RESPIRATORY HUMIDIFIER