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

Catalog Number 382-10

Device Problem False Alarm (1013)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device was not returned to the manufacturer at the time of this report.A device history record review could not be conducted since the lot number was not provided.Customer complaint cannot be confirmed based on the information received.In order to perform a proper and thorough investigation to confirm the alleged malfunction reported it is necessary to have the device sample.If the device becomes available at a later date, this report will be updated accordingly.

Event Description

Customer complaint alleges "low water alarm kept going off.(clinical specialist) walked them through water and column set up procedure.Lines were primed, water was flowing, but low water alarm continued to go off.Column changed and issue was corrected." alleged event reported as during patient use.It was reported there was no patient injury or consequence.Patient condition reported as "fine".No report of delay or interruption in therapy.No report necessary medical intervention.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and no issues were observed.The column was assembled into a concha smart neptune heater and prepared for testing by connecting a dual limb heated circuit (780-15) and a 1650ml bottle of sterile water.Ten (10) lpm of compressed air was applied to the circuit.Temperature probes were connected to manage circuit temperature.The concha smart neptune was set at 37 degrees c.The unit ran for one hour without interruption as the column successfully provided the correct amount of moisture into the dual limb heated circuit.The buildup of heavy rainout in the circuit was evidence of the column providing the necessary moisture.Prior to functional bench testing the check valves were tested.The check valve discs in all three valves would move 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 and the bottle to column dump valve opened and closed freely.To ensure the low water float in the column was working correctly, the column was assembled into the heater.The heater temperature was set at 37 degrees c with no water in the column.It was confirmed that the low water float was resting at the bottom of column as the low water blinking warning light appears on the face of the heater within 3-4 minutes of turning the heating unit on.This test confirmed that the low water warning alarm system was working.A device history record review was performed on the batch number of the returned sample and no issues or discrepancies were found which could potentially relate to this complaint.The reported complaint that the low water alarm kept coming on cannot be confirmed.It should be noted that this complaint was written up against the column.The columns do not alarm, but are equipped with a magnetic sensor inside the column that initiates the neptune to alarm when the water in the column reaches an unaccepted (low) level.The unit did not alarm at all during testing.The complaint cannot be confirmed.

Event Description

Customer complaint alleges "low water alarm kept going off.(clinical specialist) walked them through water and column set up procedure.Lines were primed, water was flowing, but low water alarm continued to go off.Column changed and issue was corrected." alleged event reported as during patient use.It was reported there was no patient injury or consequence.Patient condition reported as "fine".No report of delay or interruption in therapy.No report necessary medical intervention.

• Brand Name: HUDSON UNIVERSAL CONCHA COLUMN
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6961354
• MDR Text Key: 90589535
• Report Number: 3004365956-2017-00371
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141940
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial,Followup
• Report Date: 10/10/2017

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: No Information
• Device Catalogue Number: 382-10
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2017
• Initial Date FDA Received: 10/19/2017
• Supplement Dates Manufacturer Received: 11/10/2017
• Supplement Dates FDA Received: 11/28/2017
• 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