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

Model Number 20-0950

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Perforation (2001); Abdominal Distention (2601)

Event Date 03/11/2023

Event Type  Death  

Manufacturer Narrative

The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 17-apr-2023 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.Device not returned.

Event Description

It was reported there was "an issue in which a dobhoff tube caused a duodenal perforation." additional information received 23-apr-2023 noted the user stated "there was no issue with the actual placement.But the patient had pain when flushing the tube and feeds, which prompted them to get a [computed tomography] ct and that showed the tip of tube perforated in the duodenum.The user does not believe the device was at fault and it was just the nature of the patient, but has to report it anyway." the software version of the device is being used is unknown.

Manufacturer Narrative

H6/health impact: appropriate term/code not available: death.The cortrak-2 hardware version is 1.3.1, gui version 2.5.4.All information reasonably known as of 18-may-2023 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

Additional information received 01-may-2023 stating placement confirmed by x-ray.The tube was placed on (b)(6) 2023 at 3:50pm.The patient was no intubated at that time.On (b)(6) 2023, it was noted by the bedside registered nurse (rn that the patient seemed to moan with medication administration.A chest x-ray (cxr) was performed at 11:07am and confirmed feeding tube is distal to the diaphragm.At 12:00pm the patient was restless with when flushes were performed on the tube.At 4:00pm abdominal distension was noted.Bowel sounds were present.Abdominal characteristics-slightly distended/soft.Tube feeding started at 10cc/hr.On (b)(6) 2023 at 8:00am, a gastrointestinal (gi) assessment noted abdominal distension.Bowel sounds present.Abdominal characteristics-distended, tender.The patient was exhibiting pain and wincing when medications and fluids were pushed through the digestive health tube (dht).The critical care medicine (ccm) resident made aware as well as the complaint of tender abdomen.At 8:58am the patient was intubated.At 9:19am the cxr findings noted "endotracheal tube terminates 3 cm above the carina.Feeding tube courses sub-diaphragmatically." at 12:10pm bowel/peritoneum/retroperitoneum findings note the "distal duodenum/duodenojejunal junction is perforated with extraluminal extension of the feeding tube as noted above.There is resultant moderate inspissated fluid within the pararenal space, right more than left with pneumoretroperitoneum also extending around the left adrenal.Gas also extends around prehepatic inferior vena cava (ivc).Free fluid also extends into the peritoneum more so on the right side." the user facilities policy and main method used for confirmation of initial tube placement is the small-bore feeding tube policy.Cortrak 2 and extended cxr are used for initial placement & placement confirmation.There was no unusual patient anatomy reported.The tube was inserted to 105 cm (into left nare, utilizing cortrak 2).Additional information received 04-may-2023 stated patient "ceases to breath, patient expired".Additional information received 09-may-2023 stated patient died on (b)(6) 2023 at 4:51am.The cause of death interpretation notes the patient had "intraparenchymal hemorrhage as preliminary cause of death." follow-up with the user notes the image of the cortrak screen with monitor unit and receiver unit numbers cannot be confirmed to be the cortrak device used to place the dobhoff tube for this event.The user notes this "is one of several cortraks we have the tracings were removed from the cortrak after placement nursing staff does not know which cortrak was used." additionally, progress notes the date of placement to be on (b)(6) 2023 at 4:40pm and not 3:50pm as previously noted.The tube was inserted through the left nare and secured at 105cm with a nasal bridle by the nurse.

Manufacturer Narrative

The investigation was reviewed and completed based on the information provided by the user.An image of the tracings associated with this incident was provided and reviewed by the avanos medical inc.Per review, the anterior view, lateral view, and depth cross-sectional views do not follow typical placement patterns.Since these were images of final tracings (and not copies of the corview tracings itself that can be reviewed) it is difficult to ascertain if user had difficulty during placement.These images did not convey if multiple attempts were needed.Additionally, images of the optimal tracing pattern (in each view) that should be displayed on monitor unit (mu) screen are provided in cortrak2 eas quick reference guide, operating and troubleshooting tips, and operator¿s manual.Per timeline of events from complaint description, a feeding tube had been placed on (b)(6) 2023 and placement was confirmed by facility protocol (x-ray).On (b)(6) at 8am it was noted by the bedside registered nurse (rn) that the patient seemed to moan with med administration.Customer completed an additional x-ray at 11:07am and confirmed feeding tube was in correct location.On (b)(6), the patient continued to experience symptoms of abdominal distress, patient was intubated, and another x-ray was conducted.This x-ray confirmed duodenal perforation.Due to the feeding tube placement being confirmed multiple times through x-ray by facility protocol and that the image of tracings showed that the anterior view, lateral view, and depth cross-sectional views did not follow typical placement patterns; the root cause of this incident was determined to be "user: incorrect use" error.All information reasonably known as of 13-jul-2023 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 21 cfr 803, 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.

• 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
• Manufacturer (Section G): MINNETRONIX, INC.; 1635 energy park dr.; saint paul MN 55108
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 16761338
• MDR Text Key: 313497731
• Report Number: 3011270181-2023-00025
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00350770472010
• UDI-Public: 00350770472010
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220588
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 07/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 20-0950
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Death
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 60 KG