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

Model Number	20-0950
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Death (1802); Low Oxygen Saturation (2477)
Type of Reportable Event	Death
Additional 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 01-oct-2018 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).The device was not returned.
Event or Problem Description
A medwatch (mw) report, fda report number fda 3500 form (b)(4), was received.It was reported that a feeding tube was placed using the cortrak 2 system.Wave form the same as wave placement from 2 days earlier.Kidney, ureter, and bladder (kub) x-ray obtained due to cortrak being only at 45 mark to make sure it was in the stomach.A doctor told bedside nurse it was ok to use.When bedside nurse went to use tube, there was a large amount of blood coming from the tube.Had secretary call radiology to get a stat reading on the x-ray.The tube was removed in the meantime radiology md stated the tube was in the right lung.The pt began to decline with decreasing blood oxygen saturation (spo2) and eventually to the point a code blue was called, during the very lengthy code, the husband was called and he said to stop the code the code blue was stopped and pt expired.Another doctor was present for the code.When asked he said not to call the medical examiner as it was not needed.
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.All information reasonably known as of 25-oct-2018 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).
Additional Manufacturer Narrative
The device history record for the reported lot number, 1605001, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.One (1) cortrak eas unit was returned.The monitor unit was inspected for damages and breakages, there were no breakages or damages found on the blue housing and orange button.The device was evaluated by connecting the returned monitor unit, smart receiver unit (sru) interconnect cable to the lab's anatomical model and transmitting stylet.Functional testing of the unit indicated that the unit works as intended.After the setup, verification of the cortrak system and the completion of the initialization, the functionality of the unit performed as intended.The complaint could not be confirmed because the placement tracings were not present.The root cause was not identified.All information reasonably known as of 11-dec-2018 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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).

• Common Device Name: DH CORTRAK (EAS)
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7924738
• Report Number: 3006646024-2018-00034
• Device Sequence Number: 1787217
• Product Code: KNT
• UDI-Device Identifier: 10815149024582
• UDI-Public: 10815149024582
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K113351
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 20-0950
• Device Catalogue Number: 104720100
• Device Lot Number: 1605001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/04/2018
• Supplement Date Received by Manufacturer: 10/03/2018; 11/13/2018
• Initial Report FDA Received Date: 10/01/2018
• Supplement Report FDA Received Date: 10/26/2018; 12/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 70 YR