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

Catalog Number 382-50

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 03/17/2017

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 at the time of this report.A device history record review shows that the product was assembled and inspected according to our specifications.No corrective actions can be implemented due the lack of product sample to perform a proper investigation and determine the root cause.Customer complaint cannot be confirmed.If the device sample becomes available at a later date this report will be updated with the evaluation results.

Event Description

Customer complaint alleges the column had volume loss which was the source of the patient losing volume from the vent.It was reported the "patient's co2 was up 16 points" which improved after changing the column.Alleged defect was detected during use.Patient's condition reported as "fine".

Manufacturer Narrative

(b)(4).Lot# corrected to 74f1602711.The sample was returned for evaluation.A visual exam was performed and no defects were observed.Functional testing was performed by placing the column into a fully functioning concha neptune heater.The neptune was turned on: temperature set at 37 degrees c, max rainout, invasive mode.After approximately 3-4 minutes, the low water indicator lamp came on confirming the low water float in the column was fully functional.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 the bottle to column dump valve opened and closed freely.The returned column was connected to a concha water bottle in the correct positioning and both upper and lower tubes were punctured into the concha water bottle.The lower tubing filled as expected.(con't) other remarks: the column was then connected to a comfort flo circuit and cannula using a 3lpm flow.The nasal nares were occluded 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 functional issues found with the returned column.

Event Description

Customer complaint alleges the column had volume loss which was the source of the patient losing volume from the vent.It was reported the "patient's co2 was up 16 points" which improved after changing the column.Alleged defect was detected during use.Patient's condition reported as "fine".

• Brand Name: HUDSON UNIVERSAL CONCHA COLUMN
• Type of Device: RESPIRATORY GAS HUMIDIFIER
• 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: 6431292
• MDR Text Key: 70763319
• Report Number: 3004365956-2017-00117
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 382-50
• Device Lot Number: 74F1602711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2017
• 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
• Treatment: SERVO-I PRVC-SIMV VENTILATOR