MAUDE Adverse Event Report: HALYARD HEALTH CORTRAK ENTERAL ACCESS SYSTEM; DH CORTRAK (EAS)

Model Number	20-0950
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	Death (1802); Pneumothorax (2012)
Date of Event	05/18/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.A review of the device history record is in-progress.Upon completion of the sample evaluation and investigation; a follow-up report will be filed.All information reasonably known as of 19-jun-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 halyard health 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 halyard health.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.(b)(4).
Event or Problem Description
It was initially reported that the sru ports did not work on a cortrak unit.The user was unable to print or download placement files.The printer from the problem unit was swapped to another unit and it worked without issue.The issue surrounded the usb ports.Further information received on 21-may-2018 stated that a patient experienced pneumothorax after placement.However, the cortrak tracing and x-ray verified that the tube was placed correctly.The facility did not feel that the pneumothorax was a result of the nasogastric (ng) tube placement.Additional information received on 30-may-2018 stated that the ng tube was found in the plueral space on (b)(6) 2018.The tube was placed on (b)(6) 2018 and the facility stated that the event occurred due to user error.The only issue was that the unit was not printing the tracing.The patient later expired on (b)(6) 2018, but it was noted as unrelated to this event.
Additional Manufacturer Narrative
Halyard health received one (1) cortrak unit that was returned with a case shipper.The following components were returned with the monitor unit: sru (smart receiver unit) - lot number - 1705024, interconnect cable, battery pack, power cord, user manual.The root cause of the incident of lung placement reported was determined to be an incorrect use.The sample evaluation performed to the returned unit found evidence of what appeared to be atypical placement on the date of the event.The unit did not appear to be malfunctioning when the placement was taken.Halyard health performed a system evaluation tracing and the sru was able to provide an accurate deployment of the transmitting stylet tip during the entire placement, without any failures.The device history record for the reported lot number, 1703000, was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.All information reasonably known as of 31-aug-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 halyard health 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 halyard health.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.(b)(4).

• Brand Name: CORTRAK ENTERAL ACCESS SYSTEM
• Common Device Name: DH CORTRAK (EAS)
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7620901
• Report Number: 3006646024-2018-00026
• Device Sequence Number: 19230083
• Product Code: KNT
• UDI-Device Identifier: 10815149024698
• UDI-Public: 10815149024698
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K113351
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2018

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: 1703000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/21/2018
• Supplement Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 06/20/2018
• Supplement Report FDA Received Date: 09/06/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Other
• Patient Age: 74 YR