BEUDAMED
    FDA Adverse Event Death Summary report: N

    AVANTA FLUID MANAGEMENT SYSTEM

    MDR report key: 8848008 · Received July 31, 2019

    Report

    Report Number
    2520313-2019-00033
    Event Type
    Death
    Date Received
    July 31, 2019
    Date of Event
    June 19, 2019
    Report Date
    August 21, 2019
    Manufacturer
    BAYER MEDICAL CARE, INC.
    Product Code
    DXT
    PMA / PMN Number
    K050456
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    AN ERROR WAS MADE IN SUBMITTING THIS FOLLOW UP AND IT WAS ACCIDENTLY SUBMITTED FOR 2520313-2019-00003 WHEN IT SHOULD HAVE BEEN FOR 2520313-2019-00033. PLEASE DELETE THE ERROR AND ACCEPT THIS FOLLOW FOR THE CORRECT REPORT NUMBER 2520313-2019-00033.

    Description of Event or Problem · 0

    THE CUSTOMER SENT A NOTIFICATION TO ANSM (FRENCH NATIONAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS SAFETY) ON (B)(6) 2019. IN THE ANSM NOTIFICATION, THE FOLLOWING EXCERPT OF INFORMATION WAS PROVIDED: DURING A CORONARY ANGIOGRAM THE PATIENT SUFFERED A CORONARY GAS EMBOLISM WITH CARDIOGENIC SHOCK AND DEATH. NO TECHNICAL FAILURE WAS NOTED ON THE INJECTOR AND ON THE SINGLE-USE LINE USED. A POTENTIAL GAP IN THE INJECTION SYSTEM PURGING PROCEDURE WAS INDICATED IN THEIR REPORT.

    Additional Manufacturer Narrative · 1

    BAYER SERVICE COMPLETED A CHECK OF THE INJECTOR ON JULY 24, 2019 AND FOUND IT TO BE PERFORMING TO SPECIFICATION. THE ONLY DISPOSABLE INVOLVED IN THE PROCEDURE THAT WAS RETAINED BY THE CUSTOMER WAS AN AVA 500 SPAT L; HOWEVER, THE PACKAGING FROM THE DISPOSABLE WAS NOT SAVED. THE SITE BELIEVES THAT THE DISPOSABLE WAS FROM LOT NUMBER 182703. BATCH ACCEPTANCE TESTING FOR LOT NUMBER 182703 CONFIRMED ALL TEST RESULTS TO BE ACCEPTABLE. ON JULY 26, 2019, BAYER PRODUCT ANALYSIS RECEIVED AND FUNCTIONALLY TESTED THE AVA 500 SPAT L DISPOSABLE FROM THIS INCIDENT. THE RETURNED DISPOSABLE WAS FOUND TO PERFORM TO SPECIFICATION. INITIAL TRAINING ON THIS AVANTA UNIT WAS PERFORMED BY A BAYER REPRESENTATIVE ON APRIL 2, 2015. THE SITE INDICATED THEY WOULD LIKE ADDITIONAL APPLICATIONS TRAINING AND THIS IS BEING ARRANGED. THE AVANTA OPERATION MANUAL PROVIDES THE FOLLOWING WARNING: "TO MINIMIZE AIR EMBOLIZATION RISKS, ENSURE THAT ONE OPERATOR IS DESIGNATED AS BEING RESPONSIBLE FOR FILLING THE SYRINGE(S). DO NOT CHANGE OPERATORS DURING THE PROCEDURE. IF AN OPERATOR CHANGE MUST OCCUR, ENSURE THAT THE NEW OPERATOR VERIFIES THAT AIR HAS BEEN REMOVED FROM THE FLUID PATH".

    Description of Event or Problem · 1

    THE SITE BIOMEDICAL ENGINEER REPORTED TO A BAYER SERVICE REP THE FOLLOWING: "I HAVE BEEN INFORMED OF A PATIENT DEATH THAT COULD BE LINKED TO A LACK OF PRIMING WITH AN AVANTA INJECTOR." VERY LITTLE INFORMATION IS CURRENTLY AVAILABLE AND AN INVESTIGATION IS IN PROGRESS AT THE SITE. CONCLUSIONS OF THE SITE INVESTIGATION WILL BE SHARED WITH BAYER. ON JULY 9, 2019, THE CUSTOMER CONTACTED BAYER QUALITY IN (B)(4) AND REQUESTED AN ADDITIONAL COPY OF THE AVANTA OPERATION MANUAL AND QUICK REFERENCE GUIDE. THE LOCAL BAYER (B)(4) EXPERT SPOKE TO THIS CUSTOMER. DURING THAT CALL, THE CUSTOMER ACKNOWLEDGED THAT THE FINAL USER IS RESPONSIBLE FOR PRIMING AND CHECKING THAT THERE IS NO AIR IN THE TUBING/SYSTEM. HOWEVER, THE CUSTOMER FURTHER INDICATED THAT THE HOSPITAL WAS NOT FOLLOWING A PROTOCOL TO ENSURE THAT THE FINAL USER PRIMES AND CHECKS FOR PURGED AIR. INSTEAD, THE HOSPITAL'S PROCEDURE WAS FOR THE SHIFT THAT ENDS THE LAST PROCEDURE TO PREPARE THE EQUIPMENT FOR THE NEXT SHIFT. THIS PRACTICE ALLOWS THE STAFF TO SAVE TIME BUT LEADS TO A LACK OF VERIFICATION OF PURGING OF AIR FROM THE SYSTEM BY THE NEXT SHIFT. THE CUSTOMER HAS INFORMED THEIR STAFF THAT THIS PRACTICE IS NOT RECOMMENDED AND HAS REQUESTED ADDITIONAL TRAINING BY BAYER, DATE TO BE DETERMINED. ON JULY 11, 2019 A TELEPHONE MEETING WITH THE SITE BIOMEDICAL ENGINEER AND BAYER (B)(4) QUALITY OCCURRED. DURING THAT CALL, THE CUSTOMER REPORTED THAT THE INCIDENT OCCURRED ON (B)(6) 2019 AND THE PATIENT DIED THE SAME DAY DUE TO PULMONARY GASEOUS EMBOLISM. THE CUSTOMER DOES NOT CONSIDER THAT THE INJECTOR (SERIAL NUMBER (B)(4)) FAILED AND BAYER HAS BEEN ADVISED THAT THE INJECTOR IS STILL BEING USED BY THE SITE WITHOUT ANY ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638937 AVANTA FLUID MANAGEMENT SYSTEM ANGIOGRAPHIC INJECTOR DXT BAYER MEDICAL CARE, INC. 58746413

    Patients

    Seq Age Sex Outcome Treatment
    1 Death