BEUDAMED
    FDA Adverse Event Death Summary report: N

    AVANTA FLUID MANAGEMENT SYSTEM

    MDR report key: 9196638 · Received October 16, 2019

    Report

    Report Number
    2520313-2019-00046
    Event Type
    Death
    Date Received
    October 16, 2019
    Date of Event
    September 18, 2019
    Report Date
    November 12, 2019
    Manufacturer
    BAYER MEDICAL CARE, INC.
    Product Code
    DXT
    PMA / PMN Number
    K050456
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A SERVICE SYSTEM CHECKOUT WAS PERFORMED BY BAYER SERVICE ON SEPTEMBER 20, 2019. REVIEW OF THE INJECTOR SYSTEM FLIGHT RECORDER HISTORY BY FIELD SERVICE ENGINEER FOUND OCCURRENCES OF ERRORS 3029, 3016, AND 300. SERVICE REPLACED THE SBC COMPONENT AND RELOADED THE SYSTEM SOFTWARE RESTORING THE SYSTEM TO NORMAL OPERATION. PRODUCT ANALYSIS RECEIVED AND FUNCTIONALLY TESTED THE SUSPECT SBC COMPONENT (GRAPHICS PCB) AND FOUND THE COMPONENT FUNCTIONED TO SPECIFICATIONS. THERE IS NO EVIDENCE OF PRODUCT MALFUNCTION AT THIS TIME. THE DISPOSABLES USED IN THE REPORTED OCCURRENCE HAVE BEEN DISCARDED; HOWEVER, LOT NUMBERS HAVE BEEN PROVIDED TO BAYER. PRODUCT ANALYSIS RECEIVED AND FUNCTIONALLY TESTED THE RETAINED SAMPLES OF THE LOT NUMBERS PROVIDED. THESE RETAINED SAMPLES WERE FOUND TO PERFORM TO SPECIFICATIONS. A BAYER CLINICAL SUPPORT SPECIALIST COMPLETED A TWO-DAY SITE VISIT ON SEPTEMBER 26-27TH, 2019 AND PROVIDED REVIEW OF PROPER TECHNIQUES AND OPERATION OF THE SYSTEM. THE CUSTOMER ALSO REAFFIRMED THAT THE DEATH OF THE PATIENT WAS NOT LINKED TO THE INJECTOR OR ITS PERFORMANCE. THIS INFORMATION DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, THE COMPANY OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT.

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS RECEIVED FROM THE CUSTOMER: AN 88-YEAR-OLD, FEMALE PATIENT WAS UNDERGOING TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) VIA A PERCUTANEOUS APPROACH. DURING THE PROCEDURE, THE AVANTA FLUID MANAGEMENT SYSTEM PRESENTED WITH ERROR CODES 3029, 3016, AND 300. THE STAFF ATTEMPTED TO RESTART THE SYSTEM THREE TIMES WITHOUT SUCCESS. THE PATIENT WAS REPORTED TO EXPIRE. THE HOSPITAL STAFF STATED THAT THE DEATH OF THE PATIENT WAS NOT RELATED TO THE REPORTED ERROR MESSAGES AND/OR THE INJECTOR SYSTEM. DURING THE MIDDLE OF THE PROCEDURE, ACCORDING TO THE PHYSICIAN INVOLVED, THE PATIENT HAD BLOCKAGES IN THE AORTA AND THE CORONARY ARTERY OF UNKNOWN ETIOLOGY. THE PHYSICIAN SUSPECTED THAT THE BLOCKAGES WERE LIKELY DUE TO DETACHMENT OF ATHEROMA PLAQUE.

    Additional Manufacturer Narrative · 1

    A SERVICE SYSTEM CHECKOUT WAS PERFORMED BY BAYER SERVICE ON SEPTEMBER 20, 2019. REVIEW OF THE INJECTOR SYSTEM FLIGHT RECORDER HISTORY FOUND OCCURRENCES OF ERRORS 3029, 3016, AND 300. THE ERRORS REFER TO POTENTIAL SOFTWARE OR SBC (SINGLE BOARD COMPUTER) CARD PERFORMANCE. SERVICE REPLACED THE SBC COMPONENT AND RELOADED THE SYSTEM SOFTWARE RESTORING THE SYSTEM TO NORMAL OPERATION. THE RETURNED SBC IS BEING SENT FOR EVALUATION AT BAYER SERVICE DEPOT. BAYER WILL ISSUE A FOLLOW UP REPORT WITH THE OUTCOME OF THE TESTING UPON COMPLETION. THE DISPOSABLES USED IN THE REPORTED OCCURRENCE HAVE BEEN DISCARDED; HOWEVER, LOT NUMBERS HAVE BEEN PROVIDED TO BAYER. PRODUCT ANALYSIS RECEIVED AND FUNCTIONALLY TESTED THE RETAINED SAMPLES OF THE LOT NUMBERS PROVIDED. THESE RETAINED SAMPLES WERE FOUND TO PERFORM TO SPECIFICATIONS. A BAYER CLINICAL SUPPORT SPECIALIST COMPLETED A TWO-DAY SITE VISIT ON (B)(4) 2019 AND PROVIDED REVIEW OF PROPER TECHNIQUES AND OPERATION OF THE SYSTEM. THE CUSTOMER ALSO REAFFIRMED THAT THE DEATH OF THE PATIENT WAS NOT DIRECTLY LINKED TO THE INJECTOR OR ITS PERFORMANCE.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS RECEIVED FROM THE CUSTOMER: A (B)(6) FEMALE PATIENT WAS UNDERGOING TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) VIA A PERCUTANEOUS APPROACH. DURING THE PROCEDURE, THE AVANTA FLUID MANAGEMENT SYSTEM PRESENTED WITH ERROR CODES 3029, 3016, AND 300. THE STAFF ATTEMPTED TO RESTART THE SYSTEM THREE TIMES WITHOUT SUCCESS. THE PATIENT WAS REPORTED TO EXPIRE. THE HOSPITAL STAFF STATED THAT THE DEATH OF THE PATIENT WAS NOT RELATED TO THE REPORTED ERROR MESSAGES AND/OR THE INJECTOR SYSTEM. DURING THE MIDDLE OF THE PROCEDURE, ACCORDING TO THE PHYSICIAN INVOLVED, THE PATIENT HAD BLOCKAGES IN THE AORTA AND THE CORONARY ARTERY OF UNKNOWN ETIOLOGY. THE PHYSICIAN SUSPECTED THAT THE BLOCKAGES WERE LIKELY DUE TO DETACHMENT OF ATHEROMA PLAQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    991865 AVANTA FLUID MANAGEMENT SYSTEM ANGIOGRAPHIC INJECTOR DXT BAYER MEDICAL CARE, INC. 59352532

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death