BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTRAK*2 ENTERAL ACCESS SYSTEM

    MDR report key: 7477846 · Received May 1, 2018

    Report

    Report Number
    3006646024-2018-00016
    Event Type
    Injury
    Date Received
    May 1, 2018
    Date of Event
    March 14, 2018
    Report Date
    June 1, 2018
    Manufacturer
    HALYARD HEALTH
    Product Code
    KNT
    UDI-DI
    10815149024698
    PMA / PMN Number
    K113351
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS REPORTED TO BE AVAILABLE, BUT HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 01-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

    ONE SAMPLED DEVICE WAS RECEIVED. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 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. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE HALYARD HEALTH 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 A HALYARD HEALTH PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    THE DHR NOTED THE PROCESS HAS NOT CHANGED FOR THE MANUFACTURING OF THE CORTRAK UNIT. THE UNIT PASSED ALL REQUIRED INSPECTIONS AND WAS WORKING AS EXPECTED PRIOR RELEASE. 1 CORTRAK UNIT THAT WAS RETURNED WITH THE ORIGINAL CASE SHIPPER. THE FOLLOWING COMPONENTS WERE RETURNED WITH THE MONITOR UNIT: SRU - LOT NUMBER 1212007, 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. EVALUATION BEGAN BY ATTACHING THE RETURNED MONITOR UNIT, SRU, INTERCONNECT CABLE TO THE LAB'S ANATOMICAL MODEL, TRANSMITTING STYLET. FUNCTIONAL TESTING OF THE UNIT INDICATED THAT THE UNIT WORKED AS INTENDED. THE SMART RECEIVER UNIT (SRU) 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 ALL THE TIME. THE SMART RECEIVER UNIT WAS ABLE TO PROVIDE AN ACCURATE DEPLOYMENT OF THE TRANSMITTING STYLET TIP DURING THE ENTIRE SIMULATION 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. 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. THE EVALUATION TRACING TO THE RETURNED UNIT AND THE SRU WERE ABLE TO PROVIDE AN ACCURATE DEPLOYMENT OF THE TRANSMITTING STYLET TIP DURING THE ENTIRE PLACEMENT, WITHOUT ANY FAILURES. FOR THIS REASON, THE ROOT CAUSE "USER: INCORRECT USE" WAS SELECTED. THE ROOT CAUSE WAS USE ERROR. 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 A PNEUMOTHORAX WAS DISCOVERED AFTER THE NASOGASTRIC TUBE (NGT) PLACEMENT. THE X-RAY REVEALED A LUNG PNEUMOTHORAX. A CHEST TUBE WAS PLACED AND A PIGTAIL CATHETER WAS INSERTED TO AID IN RESOLVING THE PNEUMOTHORAX. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320916 CORTRAK*2 ENTERAL ACCESS SYSTEM DH CORTRAK (EAS) KNT HALYARD HEALTH P20-0950 1301034 10815149024698

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention