MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORTRAK 2 ENTERAL ACCESS SYSTEM; DH CORTRAK (EAS)

Model Number 20-0950

Device Problem Malposition of Device (2616)

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Date 08/20/2019

Event Type  Death  

Manufacturer Narrative

The sample is reported to be available, but has not yet been received by the manufacturer.A review of the device history record is in-progress.All information reasonably known as of 02-oct-2019 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical, inc.Represents all of the known information at this time.Avanos medical, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical, inc.Complaint database and identified as complaint (b)(4).The device was not returned.

Event Description

It was reported that during a second attempt of a nasogastric tube insertion the patient went in cardiac arrest.The image displayed on the cortrak 2 monitor showed the feeding tube placement via the esophagus to stomach and no indication of misplacement.The registered nurse (rn), "did not feel as though the arrest was directly related to the tube placement or the device." additional information received (b)(6) 2019 stated, "the record indicates that between 7:08pm and 8:00pm on (b)(6) 2019 a two person cortrak team was attempting to place a feeding tube on a patient with a history of cardiac arrest while in hospital.During the course of the attempt to place the feeding tube the patient went into cardiac arrest, the patient was resuscitated and transferred to the micu [medical intensive care unit] where it is reported that the patient arrested and was resuscitated a couple of additional times before the hospital received a dnr [do not resuscitate] order from the family, the patient passed away later that night." "there were two rn cortrak operators, one very experienced and one a new team member finishing up a three month proctoring.They were never able to complete the placement of the feeding tube due to the patient being argumentative and then have a cardiac arrest.The cortrak operators later learned that the patient was terminally ill and that the patients daughter in [another state] who had poa [power of attorney] and a dnr was traveling to the hospital.Due to the repeated cardiac arrests the local family placed the dnr at the daughters request." additional information received 02-oct-2019 stated the device placed on (b)(6) 2019 between the hours 7:08pm to 8:01pm.As noted previously while attempting to place a tube using the cortrak the patient went into cardiac arrest, the patient was transferred immediately to the micu.The patient is not deceased.No additional information was provided.

Manufacturer Narrative

Correction: b5.(typo).The device history record for the reported lot number, 1308014, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of 15-jan-2020 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical, inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical, inc.Avanos medical, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical, inc.Product is defective or caused serious injury.

Event Description

Correction: the patient is deceased.

• Brand Name: CORTRAK 2 ENTERAL ACCESS SYSTEM
• Type of Device: DH CORTRAK (EAS)
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 9150380
• MDR Text Key: 161023307
• Report Number: 3006646024-2019-00021
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00350770472010
• UDI-Public: 00350770472010
• Combination Product (y/n): N
• PMA/PMN Number: K113351
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20-0950
• Device Catalogue Number: 104720102
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/10/2019
• Initial Date FDA Received: 10/03/2019
• Supplement Dates Manufacturer Received: 12/23/2019
• Supplement Dates FDA Received: 01/15/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention