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

Catalog Number 382-10

Device Problems Filling Problem (1233); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 12/05/2016

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).The investigation into this complaint is still in progress at the time of this report.

Event Description

Customer complaint alleges that prior to use, the water would not feed into the conchasmart column.

Manufacturer Narrative

(b)(4).A device history record (dhr) review was performed and no issues or discrepancies were found which could potentially relate to the reported complaint.No rejection report was originated for the lot in question that can be associated to the complaint reported.Dhr shows that the product was assembled and inspected according to specifications.The sample was not returned for evaluation; therefore the complaint could not be confirmed.If the sample is returned, a follow-up report will be submitted with investigation results.

Event Description

Customer complaint alleges that prior to use, the water would not feed into the conchasmart column.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.The column was placed in a neptune and connected to a 1650ml water bottle.Water immediately filled the lower tube and into the column.The column was dried and set up in a heater and connected to a full 1650ml water bottle on a ventilator with pressure control settings (peep = 8, peak inspiratory pressure = 30, inspiratory time = 0.8, and rate = 30-40).The low water alarm did not turn on.The column was then dried and set up the same way but with an empty water bottle.The low water alarm did turn on.This behavior is expected and normal.Next, the column was dried and set up the same way but with a low water bottle (enough water to fully submerge the puncture pin).Water immediately filled in the lower tube and the low water alarm did not turn on.Next, the column was dried out and placed on a ventilator with the same settings for about 40 hours.Again, the column filled with water instantly and there was no low water alarm for the duration of the test.Based on the investigation performed, the reported complaint could not be confirmed.The column acted normally and no issues were detected.The alarm only came on when the water bottle was empty.

Event Description

Customer complaint alleges that prior to use, the water would not feed into the conchasmart column.

• 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: 6210164
• MDR Text Key: 63417162
• Report Number: 3004365956-2016-00467
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2016
• 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: 74D1602325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2017
• 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