BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTRAK ENTERAL ACCESS SYSTEM

    MDR report key: 7486957 · Received May 4, 2018

    Report

    Report Number
    3006646024-2018-00018
    Event Type
    Injury
    Date Received
    May 4, 2018
    Date of Event
    March 29, 2018
    Report Date
    June 1, 2018
    Manufacturer
    HALYARD HEALTH
    Product Code
    KNT
    UDI-DI
    10680651472011
    PMA / PMN Number
    K113351
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 03-MAY-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).

    Additional Manufacturer Narrative · 1

    HALYARD HEALTH RECEIVED ONE 1 CORTRAK UNIT THAT WAS RETURNED WITH A CASE SHIPPER. THE FOLLOWING COMPONENTS WERE RETURNED WITH THE MONITOR UNIT: SMART RECEIVER UNIT (SRU) - LOT NUMBER 1211021, INTERCONNECT CABLE, BATTERY PACK, POWER CORD. THE MONITOR UNIT WAS INSPECTED FOR DAMAGES AND BREAKAGES, THERE WERE NO BREAKAGES OR DAMAGES FOUND ON THE BLUE HOUSING AND ORANGE BUTTON. PLACEMENT EVALUATION WAS STARTED BY ATTACHING THE RETURNED MONITOR UNIT, SRU, INTERCONNECT CABLE TO THE LAB'S ANATOMICAL MODEL, TRANSMITTING STYLET. FUNCTIONAL TESTING OF THE UNIT INDICATES THAT THE UNIT WORKS AS INTENDED. THE SMART RECEIVER UNIT WAS ABLE TO COMMUNICATE WITH THE MONITOR UNIT, INTERCONNECT CABLE, TRANSMITTING STYLET, ANATOMICAL MODEL AND PERFORMED SELF-TEST WITHOUT ANY FAILURES. THE LED ON THE SRU WAS ILLUMINATING GREEN THE ENTIRE TIME. THE SMART RECEIVER UNIT WAS ABLE TO PROVIDE AN ACCURATE DEPLOYMENT OF THE TRANSMITTING STYLET TIP DURING THE ENTIRE PLACEMENT, WITHOUT ANY FAILURES. AFTER THE SETUP OF THE CORTRAK SYSTEM AND THE COMPLETION OF THE INITIALIZATION AND TESTING, THE FUNCTIONALITY OF THE UNIT PERFORMED AS INTENDED. ALSO, IN THE CUSTOMER'S RETURNED MONITOR UNIT, ON (B)(6) 2018 A POTENTIAL LUNG PLACEMENT WAS REPORTED. THE SAMPLE EVALUATION PERFORMED ON 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, INSTEAD IT APPEARS TO BE LUNG PLACEMENT THAT WOULD HAVE BEEN APPARENT TO A TRAINED CLINICIAN. FOR THIS REASON, THE ROOT CAUSE IS ATTRIBUTED TO INCORRECT USAGE BY THE USER. THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER 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 27-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. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A LUNG PLACEMENT, PNEUMOTHORAX, AND REQUIRED A CHEST TUBE. THE PATIENT WAS ADMITTED TO THE HOSPITAL 7-DAYS PRIOR FOR RESPIRATORY FAILURE AND WAS INTUBATED AND WAS ON A VENTILATOR. X-RAYS WERE PERFORMED EVERYDAY AND ON THE MORNING LEADING UP TO THIS EVENT. THERE WAS NO PNEUMOTHORAX PRESENT VIA THE X-RAYS. AFTER THE PLACEMENT WAS COMPLETED, PNEUMOTHORAX WAS CONFIRMED VIA THE X-RAY WHICH WAS PERFORMED TO VERIFY THE PLACEMENT. THE PATIENT COUGHED UP THE TUBE. THE TUBE WAS THEN GUIDED BY THE CLINICIAN INTO THE STOMACH. THE PLACEMENT WAS PERFORMED BY A DIETITIAN WHO NOTED THAT THE XIPHOID PROCESS WAS DIFFICULT TO LOCATE DUE TO THE PATIENT BEING OBESE. A CHEST TUBE WAS PLACED TO RESOLVE THE PNEUMOTHORAX THE PATIENT WAS EXTUBATED AND DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330052 CORTRAK ENTERAL ACCESS SYSTEM DH CORTRAK (EAS) KNT HALYARD HEALTH 20-0950 1211020 10680651472011

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR