CORTRAK 2 ENTERAL ACCESS SYSTEM
Report
- Report Number
- 3011270181-2023-00128
- Event Type
- Death
- Date Received
- November 1, 2023
- Date of Event
- October 3, 2023
- Report Date
- December 20, 2023
- Manufacturer
- AVANOS MEDICAL INC.
- Product Code
- KNT
- UDI-DI
- 00350770472010
- PMA / PMN Number
- K220588
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE DEVICE IN USE HAD SOFTWARE VERSION 2.4.8. ALL INFORMATION REASONABLY KNOWN AS OF 20-DEC-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.
THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, 1805009, 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 05-DEC-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.
THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 31-OCT-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. H3 OTHER TEXT: DEVICE NOT RETURNED.
ON 30-NOV-2023, THE AVANOS MEDICAL CLINICAL EDUCATION SPECIALIST (CES) MET WITH THE CLINICAL NURSE SPECIALIST (CNS) FOR THE MEDICAL INTENSIVE CARE UNIT (MICU) AND THE CNS FOR THORACIC ONCOLOGY AND THOSE RESPONSIBLE FOR THE CORTRAK TUBES PLACED IN THEIR SURGICAL INTENSIVE CARE UNIT (SICU) AND NEURO CRITICAL CARE UNIT (NCCU). THE AVANOS CES STATED ¿[REGARDING] THE PATIENT THAT I WAS INVOLVED WITH [THE INITIAL PLACEMENT], SHE HAD A TRACING ON THE MICU MACHINE BUT DID NOT HAVE THE TRACING FROM THE MACHINE THE REGISTERED DIETICIANS (RD) USED TO PLACE THE ORIGINAL TUBE. TO THE BEST OF MY RECOLLECTION, THERE WERE 2 RDS PLUS MYSELF AND 1 REGISTERED NURSE (RN) IN THE ROOM. THE PATIENT WAS MEDICALLY FRAIL, ON HIGH FLOW NASAL CANULA OXYGEN (NC O2). THE INITIAL PLACEMENT WAS INSERTED BY AN RD, THE RD WAS UNABLE TO ADVANCE THE TUBE POST PYLORIC AND DUE TO THE LENGTH OF THE PROCEDURE, THE CLINICIANS LEFT IT IN THE GASTRIC POSITION. THE RADIOLOGY READ WAS SOMETHING LIKE ¿SATISFACTORY POSITION IN THE GASTRIC REGION.¿ THE MICU CNS REPORTED TO THE AVANOS CES THAT ADDITIONAL EVENTS OCCURRED AFTER CONFIRMATION OF INITIAL PLACEMENT INTO GASTRIC REGION. APPROXIMATELY 90 MINUTES LATER, THERE WAS A NOTE BY AN ADVANCED PRACTICE PROVIDER (APP) TO THE EFFECT: DURING REPOSITIONING OF THE FEEDING TUBE, THE PATIENT HAD A CHANGE IN CLINICAL STATUS. THERE WAS A SUBSEQUENT NOTE BY THE APP THAT THE PATIENT HAD A CARDIAC ARREST AND EXPIRED AND THERE WAS EVIDENCE OF A PNEUMOTHORAX ON FOLLOW-UP IMAGING. THIS WAS APPROXIMATELY 5-HOURS AFTER THE RD TUBE PLACEMENT. THE RDS AND CNS FOUND OUT THE NEXT MORNING THAT THE PATIENT HAD EXPIRED. THE CNS WAS NOT CONTACTED TO REPOSITION THE FEEDING TUBE. THE MICU CNS EXPLAINED THAT A DIFFERENT RN, USING A DIFFERENT MACHINE, ATTEMPTED TO REPOSITION THE TUBE BECAUSE (IT WAS REPORTED TO HER) THAT THE APP WANTED THE TUBE ADVANCED POST PYLORIC. ON REVIEW OF THAT PLACEMENT FILE, THE CNS INTERPRETATION WAS THAT THE RN MUST HAVE PULLED THE TUBE BACK SIGNIFICANTLY BECAUSE THE TRACING STARTED IN THE MIDDLE OF RIGHT UPPER QUADRANT (RUQ) ON THE SCREEN (PATIENTS LEFT CHEST AREA). AFTER THAT, THERE WAS SIGNIFICANT ARTIFACT AND THE CNS WAS UNABLE TO DETERMINE WHERE THE TUBE TERMINATED, ONLY THAT THE TRACING NEVER LEFT THE RUQ OF THE SCREEN. THE AVANOS MEDICAL CES ¿SENSED FROM MY CONVERSATION WITH THE MICU CNS, SHE DIDN¿T FEEL LIKE IT WAS A RESULT OF THE INITIAL TUBE PLACEMENT, BUT MAYBE SOMETHING HAPPENED WHEN THE RN WENT IN TO ADVANCE THE TUBE.¿
IT WAS REPORTED " CORTRAK PROCEDURE WAS AT 1:53PM, AT 4:47PM A PATIENT HAD PNEUMOTHORAX PER CHEST X-RAY AND AT 9:45PM THERE IS DOCUMENTATION OF A FATAL CARDIAC ARREST. ONE OF AVANOS' CES AND FACILITY PT NURSE WAS BEDSIDE DURING THE CORTRAK PROCEDURE. TRACINGS SUPPORT A SAFE PLACEMENT UPON IMAGING- RADIOLOGY CONFIRMED TUBE LOCATION IN PROXIMAL STOMACH 2-HOURS AFTER THE PROCEDURE, PATIENT HAD A PNEUMOTHORAX IN THE RIGHT LUNG AND SUBSEQUENTLY FATAL CARDIAC EVENT. WE'RE STILL GATHERING INFORMATION AND REVIEWING CHARTING. BASED ON THE TRACING IMAGING, IT SEEMS LINKING THE EVENT TO CORTRAK PROCEDURE ALONE WOULD BE UNSUBSTANTIATED. IN REVIEWING THE TRACINGS, NO DEVIATIONS INTO THE RIGHT LUNG OBSERVED." THE PATIENT WAS NOT INTUBATED AT TIME OF TUBE PLACEMENT BUT WAS ON HIGH FLOW NASAL CANNULA OXYGEN. THE BEDSIDE NURSE IDENTIFIED THE PATIENT HAVING COMPLICATIONS AND CONSULTED THE NURSE PRACTIONER. A CHEST X-RAY (CXR) SHOWED RIGHT APICAL PNEUMOTHORAX. THE USER FACILITY REQUIRES A CONFIRMED TUBE TIP PLACEMENT FROM KIDNEY URETERS AND BLADDER KUB PRIOR TO TUBE USE. PER THE NURSE'S NOTES, THE REGISTERED NURSE (RN) MAY HAVE REPOSITIONED THE TUBE WITHOUT VISUAL GUIDANCE. CORTRAK TUBE WAS REMOVED AND NASOGASTRIC (NGT) WAS PLACED FOR GASTRIC DECOMPRESSION. ON (B)(6) 2023 PER DOCUMENTATION AT 4:47PM, "THE CORTRAK WAS REMOVED DUE TO CONCERN FOR MALPOSITION." THE DEVICE WAS REPLACED WITH NGT FOR DECOMPRESSION PER DOCUMENTATION. AT PRESENT IT WAS NOTED THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS "SIGNIFICANT EVENT (RIGHT APICAL PNEUMOTHORAX) 4:47PM ON (B)(6) AND CARDIAC ARREST AT 9:45PM. PATIENT WAS COMFORT CARE." ADDITIONAL INFORMATION RECEIVED 19-OCT-2023 MEETING WITH CLINICAL EDUCATION SPECIALIST WHO WAS ON SITE FOR INITIAL PLACEMENT NOTED "PATIENT HAD ATYPICAL ANATOMY OR DISTENDED STOMACH (NOT SURE WHICH) AND THAT TIP WAS PLACED IN PROXIMAL STOMACH. NOTHING UNUSUAL IN THE RADIOLOGIST INTERPRETATION OF THE CORTRAK TUBE AFTER INITIAL PLACEMENT. THEY ONLY COMMENTED FEEDING TUBE TIP IN PROXIMAL STOMACH. THEY DID NOT NOTE ATYPICAL ANATOMY OR GASTRIC DISTENSION IN THEIR DICTATION FROM PROGRESS NOTES, AT FACILITY FEEDING TUBE WAS MOVED AFTER INITIAL PLACEMENT PATIENT THEN STARTED HAVING SYMPTOMS, SECOND XRAY WAS CONDUCTED, AND PNEUMOTHORAX WAS FOUND."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2092148 | CORTRAK 2 ENTERAL ACCESS SYSTEM | DH CORTRAK (EAS) | KNT | AVANOS MEDICAL INC. | 20-0950 | N/A | 00350770472010 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Female | Death| O | SRU SN: (B)(6) |