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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON UNIVERSAL CONCHA COLUMN; HUMIDIFIER, RESPIRATORY GAS, (
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TELEFLEX MEDICAL HUDSON UNIVERSAL CONCHA COLUMN; HUMIDIFIER, RESPIRATORY GAS, ( Back to Search Results
Catalog Number 382-10
Device Problem Filling Problem (1233)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/31/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has been received by the manufacturer, however the investigation of said device is still in progress at the time of this report.A device history record review could not be conducted since only was received a partial of lot number (74d17) if complete lot number become available at a later date, this report will be updated accordingly.A follow up report will be filed upon completion of the device evaluation.
 
Event Description
Customer complaint alleges "no water was filled into column, thus resulting in no humidification out to patient." alleged issue reported during use.Customer reports no patient injury or consequence.Device involved was replaced with a new one with not other reported issue.
 
Manufacturer Narrative
(b)(4).The customer returned one water column (product code 382-10).The column was visually inspected for any signs of damage, misuse/abuse.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 the circuit temperature.The concha smart neptune was set at 37 degrees c.The setup with the suspected concha column ran for three hours 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.A check valve test was also performed on the column.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 valve and bottle to column valve opened and closed freely.In addition, the syringe was placed on the lower water fill tube of the column and the check valve disc opened and closed normally.The column was placed into a concha neptune heater without water.Within 3 minutes of operation the low water indicator lamp came on which validates the proper operation of the low water float in the column.A device history record (dhr) review was performed on the lot number of the returned sample.There were no issues or discrepancies found which could potentially relate to the reported complaint.The instructions for use (ifu) for this product states, "to ensure that the initial water flow through the lower tube is not blocked by surface tension in the check valve, squeeze the bottle slightly (priming).", "connect the circuit to the column.", and "allow the column to fill for at least three minutes before starting gas flow to ensure proper column filling and wick saturation".Based on the investigation performed, the reported complaint could not be confirmed.Functional testing did not reveal any operational discrepancies with the universal column.
 
Event Description
Customer complaint alleges "no water was filled into column, thus resulting in no humidification out to patient." alleged issue reported during use.Customer reports no patient injury or consequence.Device involved was replaced with a new one with not other reported issue.
 
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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 Key7044577
MDR Text Key93007354
Report Number3004365956-2017-00408
Device Sequence Number1
Product Code BTT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141940
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/31/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number382-10
Device Lot Number74D17
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/10/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/15/2017
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 Number1
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