MAUDE Adverse Event Report: HALYARD HEALTH CORTRAK 2 ENTERAL ACCESS SYSTEM; DH CORTRAK (EAS)

Model Number	P20-0950
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	06/10/2017
Type of Reportable Event	Serious Injury
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 07-jul-2017 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.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).
Event or Problem Description
A report was received stating the staff states the cortrak is not placing properly.Biomed is aware of 1 lung placement and possibly 2 more occurrences of misplacement that were not in the lung.Biomed does not have any further details.Additional information received (b)(6) 2017 stated the stat registered nurse (rn) placed the tube and the patient had a subsequent pneumothorax.Prior to the incident the cortrak unit display tracings had been going on and off.The patient developed a pneumothorax and required a pigtail computed tomography (ct) catheter to be placed.Another feeding tube was placed using the "blind" technique.On the previous day the cortrak unit had been displaying the tracings "on and off." the patient was reported to be stable from this injury.Additional information received 26-jun-2017 stated it is unknown how many misplacements occurred and the location of the misplacement.The customer stated "i am sorry but i do not.It was awhile back and i am not sure if it was this machine or not." no additional information was provided.
Additional Manufacturer Narrative
The device history record for the reported lot number, 1208010, was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.One sample device was received.The device, cortrak 2 eas, was in a used condition.The back house was cracked at the usb port end.The returned device was tested with known verified stylet, interconnected cable and anatomical model, all test results were with specifications.No failure mode observed.Customer reported complaint was not confirmed.No information was provided by the customer related to the pneumothorax placement(s) events.As a part of the device evaluation, few historical placements were saved by the customer on the internal memory of the monitor.The unit was reviewed and no abnormality was discovered.Root cause could not be determined.All information reasonably known as of 15-sep-2017 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).

• Brand Name: CORTRAK 2 ENTERAL ACCESS SYSTEM
• Common Device Name: DH CORTRAK (EAS)
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6702582
• Report Number: 3009124963-2017-00033
• Device Sequence Number: 11115855
• Product Code: KNT
• UDI-Device Identifier: 10815149024698
• UDI-Public: 10815149024698
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K113351
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2017

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: Nurse
• Device Model Number: P20-0950
• Device Catalogue Number: 104655800
• Device Lot Number: 1208010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2017
• Initial Date Received by Manufacturer: 06/13/2017
• Supplement Date Received by Manufacturer: 08/25/2017
• Initial Report FDA Received Date: 07/11/2017
• Supplement Report FDA Received Date: 09/19/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Weight: 65