MAUDE Adverse Event Report: TELEFLEX MEDICAL COMFORT FLO HUMIDIFICATION SYSTEM; HUMIDIFIER NEBULIZER KIT

Catalog Number 2410

Device Problem No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/09/2017

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).Based on the information given by the customer, there are 2 mdrs associated with this complaint.(see mdr 3011137372-2017-00221 for adult comfort flo nasal cannula).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 could not be conducted since the lot number was not provided.Customer complaint cannot be confirmed based only on the information provided.In order to perform a proper investigation and determine the source of the alleged defect reported, it is necessary to evaluate the device sample involved on this complaint.No corrective action can be established at this time.If the device sample becomes available at a later date this complaint will be updated.

Event Description

The high flow product #2410 was used with the comfort flow cannula 2411-01 (event documented in mdr 3011137372-2017-00221).The cannula built up a back pressure and stopped flow to the patient.Alleged malfunction was reported as detected during use.It was reported there was no injury or consequence to the patient.Patient's condition reported as "fine".

Manufacturer Narrative

(b)(4).Upon receipt the following items were returned for investigation: one low compliance concha column, one adult breathing circuit ventilator drop line, one adult single limb 780-19 breathing circuit, one adult breathing circuit inline medicine nebulizer, and several miscellaneous pieces of oxygen tubing with no id assignment.It should be noted that none of these individual pieces make up a 2410 comfort flo system.Also, while not reported, the 780-19 adult single limb circuit exhibited several areas where the heated wire melted the circuit.The first melted area measures 28" from the concha column end of the circuit.The melted portion of the circuit measures 4-5" long.About 5" below the first melted area is another melted area which measures 3-4" in length.There is no sign of the wires being gathered or "bunched" together.The heated wires are not charred.While the complaint description does not lend itself to the individual sample pieces received, the following tests were performed on the low compliance concha column.The stop valves on both the water dump and water return tubes were confirmed operable allowing water to flow in the correct direction and return in the correct direction.Other remarks: the column was placed into a standard concha neptune operating setup with water, air pressure, and a concha smart neptune, governing temperature and rainout.The neptune was set at 40 degrees celsius, invasive mode with heavy rainout.The neptune reached the assigned temperature of 40 degrees celsius.The low compliance column had previously been primed with sterile water.Water was flowing into the column as heavy moisture beads were forming on the inside walls of the 780-19 adult single limb heated circuit confirming the correct operation of the column.Air and moisture flow could not be confirmed or measured in the 780-19 adult single limb heated circuit due to the melted voids in the tubing.The complaint description is vague, however, in terms of flow, the column water and heated moisture were flowing.The electrical ohm resistance was measured in the 780-19 heated wire single limb breathing circuit.The actual resistance measured 13.6 ohms which is well within the accepted range.The instructions for use (ifu) for this product warns, "do not milk or stretch tubing to remove condensation.Wire damage or circuit malfunction may occur.", "do not place tubing on patient's skin", and, "do not cover tubing with sheets, blankets, towels, clothing, or other materials".The reported complaint of, "cannula built up a back pressure and stopped flow to the patient" cannot be confirmed based upon the samples received.The returned circuit was confirmed to have melted as a result of the melted corrugated tubing material.If the returned 780-19 single limb heated breathing circuit was being used in the comfort flo setup and airflow was discontinued for some reason, the circuit could melt.As well, if the circuit was placed beside the patient's skin, or if bed linen, towels, sheets, etc., were placed on top of the circuit, a melt could develop.However, all circuits are 100% inspected for leaks at the time of manufacturing so it is unlikely that this defect was present at that time.The damage observed on the circuit indicates an improper setup and lack of regular monitoring by the clinician/user.An in-service has been declined by the customer.

Event Description

The high flow product #2410 was used with the comfort flow cannula 2411-01 (event documented in mdr 3011137372-2017-00221).The cannula built up a back pressure and stopped flow to the patient.Alleged malfunction was reported as detected during use.It was reported there was no injury or consequence to the patient.Patient's condition reported as "fine".

• Brand Name: COMFORT FLO HUMIDIFICATION SYSTEM
• Type of Device: HUMIDIFIER NEBULIZER KIT
• 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: 6670820
• MDR Text Key: 78509874
• Report Number: 3004365956-2017-00266
• Device Sequence Number: 1
• Product Code: OGG
• 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
• Report Date: 06/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 2410
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/02/2017
• 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: ADULT COMFORT FLOW NASAL CANNULA