MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON UNIVERSAL CONCHA COLUMN; HUMIDIFIER, RESPIRATORY GAS, (

Catalog Number 382-10

Device Problems Failure to Prime (1492); Short Fill (1575)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/21/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved was not received for evaluation by the manufacturer at the time of this report.A device history record review, based on the lot number reported was, conducted.No issues were found that could relate to the complaint issue reported.It is necessary to have the physical sample in order to perform a proper investigation to confirm the alleged defect, and determine a root cause.Customer complaint cannot be confirmed at this time.The root cause is unknown.No corrective actions can be assigned.If the sample becomes available this report will be updated with the evaluation results.

Event Description

Customer complaint states after noticing the low water alarm notification on the nepturne heater, the respiratory therapist tried to squeeze and prime the water but no water showed in the water lines.The concha water was 1/4 to 1/2 full.(cont.) it was reported there was no injury or consequence to the patient.

Manufacturer Narrative

(b)(4).The device was further evaluated by r & d.The results of the evaluation are as follows: the complaint alleges the conchasmart column stopped flowing water from a water bottle that was to.5full of water resulting in a low water notification on the neptune heater.Upon inspection of the lower tubing the check valve disc in the valve assembly puncture pin leading to the bottom of the bottle was pushed in the closed position.We placed the column in a neptune and connected it to a full water bottle resulting in no flow through the lower tube as the complaint suggested.Tried again with a half full water bottle and again no flow.The bottle was squeezed in both instances with no movement of the lower valve as the upper valves were free to move and allowed the air to escape without moving the lower valve.We then closed the upper column tube clamp prevent air from escaping through the upper column valves and squeezed the bottle again.The lower valve remained shut with only a very small trickle of water seeping past.The lower check valve assembly was then removed from the tube and viewed under a microscope.There was water on the water bottle side of the assembly and the small bit of water on the column side of the valve.The water was wicked away from the assembly using tissue for a better view of the vale which was flat against the vale housing in closed position.Even after the white check valve cover was then removed leaving water on either side of the check valve disc and the disc still in closed position.The water from both sides of the disc was then removed with a dry paper towel and the disc was still in place.A thin wire was then used to push against the valve disc.It met with some resistance but did push open.The disc valve/valve housing assembly was then viewed from the end to see that the disc had a smaller od than the housing id as per intended design.This would signify that the disc was not stuck against the id of the valve housing rather it must have been sticking to the opening surface of the puncture pin side.After moving the valve open with the wire, the entire check valve assembly was reassembled and pushed back into the lower tubing of the column.The column was placed back into a neptune and connected to a full water bottle and flowed into the column.The flow through the lower tube was only along one side of the tube but did eventually fill the entire tube and into the column per design.After the tests above it has been concluded that the sample is completely occluded before use but the root cause is as of yet undetermined.The sample is being returned to the manufacturing site for further investigation.

Event Description

Customer complaint states after noticing the low water alarm notification on the nepturne heater, the respiratory therapist tried to squeeze and prime the water but no water showed in the water lines.The concha water was 1/4 to 1/2 full.It was reported there was no injury or consequence to the patient.

Manufacturer Narrative

(b)(4).One (1) 382-10 universal column was received for investigation.A visual inspection was performed on the column.No visible damage was noted.The check valve discs in all three valves were operable as the column valves were turned from one side to the other, showing the discs themselves were free to move.A syringe connected to the upper tube was used to push and pull upper check valves.The column to bottle/bottle to column valves opened and closed freely.The column was placed into a 425-00 neptune heater without water.The neptune was turned on and set to 37 degrees "c" , with heavy rainout.Within 3 minutes the low water indicator lamp had illuminated.The returned column was then connected to a concha water bottle in correct positioning and both upper and lower tubes were punctured into the concha water bottle.The conchasmart column filled to the bottom of the level sensing tube and stopped as expected.The column was then connected to a 2414 comfort flo circuit with a 2411-04 neonate cannula using the 3lpm flow mentioned in the report with no problems then disconnected the cannula with no water level increase into the circuit.The infant cannula was reconnected to 3lpm and occluded the nasal nares allowing the pressure to build in the bottle until the comfort flo relief valve actuated representing the worst case back pressure for the system then disconnected the airflow.The column allowed the water bottle air pressure to escape through the column without pushing the column water level up to the circuit thus functioning appropriately.The complaint was unable to be confirmed as the scenario was not able to be recreated even at the highest back pressure settings.

Event Description

Customer complaint states after noticing the low water alarm notification on the nepturne heater, the respiratory therapist tried to squeeze and prime the water but no water showed in the water lines.The concha water was 1/4 to 1/2 full.It was reported there was no injury or consequence to the patient.

• Brand Name: HUDSON UNIVERSAL CONCHA COLUMN
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 7923958
• MDR Text Key: 122312016
• Report Number: 3004365956-2018-00284
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K141940
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 382-10
• Device Lot Number: 74L1702431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2018
• Date Manufacturer Received: 11/06/2018
• Patient Sequence Number: 1
• Treatment: NEPTUNE HEATER, CONCHA WATER; NEPTUNE HEATER, CONCHA WATER; NEPTUNE HEATER, CONCHA WATER