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

Catalog Number 382-10

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/26/2018

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 at the time of this report.The device history record of batch number provided has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.In order to conduct a proper and thorough investigation, it is necessary to have the device sample involved.Customer complaint cannot be confirmed based on the information received.Root cause is unknown.Corrective actions cannot be established.If the device sample becomes available at a later date, this report will be updated accordingly.

Event Description

Customer complaint alleges "rt complained seeing water fill up in the column and flood the circuit.Changing the column resolved the issue." alleged malfunction reported occurred during use.It was reported there was no patient injury or consequence.Patient condition reported as "fine".

Manufacturer Narrative

(b)(4).One 382-10 universal column was received for investigation.A visual inspection was performed on the column.One large indention with a heavy crease measuring approximately one-half inch was identified on the body of the column.The indention did not leak during testing.Functional testing was performed and 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/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 three 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 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 the cannula was disconnected with no water level increase into the circuit.(con't) other remarks: 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.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned sample.

Event Description

Customer complaint alleges "rt complained seeing water fill up in the column and flood the circuit.Changing the column resolved the issue." alleged malfunction reported occurred during use.It was reported there was no patient injury or consequence.Patient condition reported as "fine".

• 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: 7321596
• MDR Text Key: 101978373
• Report Number: 3004365956-2018-00072
• 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: 03/01/2018

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: Health Professional
• Device Catalogue Number: 382-10
• Device Lot Number: 74L1701892
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2018
• Initial Date FDA Received: 03/07/2018
• Supplement Dates Manufacturer Received: 04/10/2018
• Supplement Dates FDA Received: 04/11/2018
• 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