BEUDAMED
    FDA Adverse Event Death Summary report: N

    CORTRAK* ENTERAL ACCESS SYSTEM

    MDR report key: 7433797 · Received April 16, 2018

    Report

    Report Number
    3006646024-2018-01140
    Event Type
    Death
    Date Received
    April 16, 2018
    Date of Event
    January 24, 2018
    Report Date
    May 17, 2018
    Manufacturer
    HALYARD HEALTH
    Product Code
    KNT
    UDI-DI
    10815149024698
    PMA / PMN Number
    K113351
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HALYARD HEALTH RECEIVED ONE (1) CORTRAK UNIT THAT WAS RETURNED WITH THE ORIGINAL CASE SHIPPER. THE FOLLOWING COMPONENTS WERE RETURNED WITH THE MONITOR UNIT: SRU - LOT NUMBER 1406015, INTERCONNECT CABLE, BATTERY PACK, POWER CORD, USER MANUAL. THE MONITOR UNIT WAS INSPECTED FOR DAMAGES AND BREAKAGES, THERE WERE NO BREAKAGES OR DAMAGES FOUND ON THE BLUE HOUSING AND ORANGE BUTTON. SAMPLE EVALUATION BEGAN WITH THE PLACEMENT EVALUATION BY ATTACHING THE RETURNED MONITOR UNIT, SRU TO THE LAB'S ANATOMICAL MODEL, TRANSMITTING STYLET, INTERCONNECT CABLE. FUNCTIONAL TESTING OF THE UNIT INDICATED 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 ALL THE TIME. PERFORMED GREEN-ALL PLACEMENT AND 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, THE FUNCTIONALITY OF THE UNIT PERFORMED AS INTENDED. THE INVESTIGATION OF THE CORTRAK SYSTEM INDICATED THE HARDWARE WAS FUNCTIONING WITHIN SPECIFICATIONS. ROOT CAUSE WAS ATTRIBUTED TO INCORRECT USE 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 07-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. 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).

    Additional Manufacturer Narrative · 1

    THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND IS BEING PROCESSED FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION; A FOLLOW-UP REPORT WILL BE FILED. ALL INFORMATION REASONABLY KNOWN AS OF 16APR2018 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).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A MEDWATCH REPORT NUMBER 5075441 WAS RECEIVED ON 21-MAR-2018 "THE PATIENT WAS ORDERED BY THE PROVIDER TO HAVE A POST PYLORIC FEEDING TUBE INSERTED. THE NURSE USED THIS PIECE OF EQUIPMENT WHILE INSERTING THE TUBE. AN X-RAY CONFIRMED THAT THE TUBE WAS PLACED IN THE PATIENT¿S LUNG CAUSING A PNEUMOTHORAX. THE PATIENT HAD AN ARREST LEADING TO A CODE BLUE." ADDITIONAL INFORMATION WAS RECEIVED ON 30-MAR-2018 FROM THE RISK MANAGER WHO STATED THE PATIENT HAD A CARDIAC RESPIRATORY ARREST THAT LEAD TO AN PEA PULSELESS ELECTRICAL ACTIVITY. THE PATIENT RECEIVED MEDICAL INTERVENTION IN THE FORM OF A CHEST TUBE, INTUBATION, NEEDLE DECOMPRESSION, CHEST TUBE AND A RIGHT FEMORAL ART LINE INSERTED. THE PATIENT EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275079 CORTRAK* ENTERAL ACCESS SYSTEM DH CORTRAK (EAS) KNT HALYARD HEALTH 20-0950 UNKNOWN 10815149024698

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death