BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVANTA FLUID MANAGEMENT SYSTEM

    MDR report key: 13536776 · Received February 15, 2022

    Report

    Report Number
    2520313-2022-00008
    Event Type
    Injury
    Date Received
    February 15, 2022
    Date of Event
    January 10, 2022
    Report Date
    February 24, 2022
    Manufacturer
    BAYER MEDICAL CARE, INC.
    Product Code
    DXT
    UDI-DI
    00616258008578
    PMA / PMN Number
    K050456
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SYSTEM SERVICE CHECK OF THE AVANTA FLUID MANAGEMENT SYSTEM WAS COMPLETED BY BAYER SERVICE AND FOUND THAT THE INJECTION SYSTEM PERFORMED TO SPECIFICATIONS. THE MULTI-PATIENT STERILE DISPOSABLE SET (MPAT) AND THE SINGLE-PATIENT STERILE DISPOSABLE SET (SPAT) THAT WERE IN USE DURING THE PROCEDURE WERE DISCARDED BY THE SITE. HOWEVER, THE SITE WAS ABLE TO PROVIDE THE LOT NUMBER OF THE MPAT SYRINGE ONLY THAT WAS IN USE. A RETAINED SAMPLE HAS BEEN REQUESTED AND WILL BE EXAMINED ONCE RECEIVED. THE CUSTOMER HAS BEEN OFFERED ADDITIONAL APPLICATIONS TRAINING AND HAS ACCEPTED. A SITE VISIT IS BEING SCHEDULED. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    A SYSTEM SERVICE CHECK OF THE AVANTA FLUID MANAGEMENT SYSTEM WAS COMPLETED BY BAYER SERVICE AND FOUND THAT THE INJECTION SYSTEM PERFORMED TO SPECIFICATIONS. THE MULTI-PATIENT STERILE DISPOSABLE SET (MPAT) AND THE SINGLE-PATIENT STERILE DISPOSABLE SET (SPAT) THAT WERE IN USE DURING THE PROCEDURE WERE DISCARDED BY THE SITE. HOWEVER, THE SITE WAS ABLE TO PROVIDE THE LOT NUMBER OF THE MPAT SYRINGE ONLY THAT WAS IN USE. A RETAINED SAMPLE HAS BEEN RECEIVED AND EXAMINED AND FOUND TO PERFORM TO SPECIFICATIONS. THE CUSTOMER HAS BEEN OFFERED ADDITIONAL APPLICATIONS TRAINING AND HAS ACCEPTED. A SITE VISIT IS BEING SCHEDULED. 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 CUSTOMER REPORTED TO A BAYER REPRESENTATIVE THAT AN ALLEGED AIR INJECTION OCCURRED ON A (B)(6) MALE PATIENT WHILE UTILIZING THE AVANTA FLUID MANAGEMENT SYSTEM ((B)(4)) TO PERFORM A CORONARY ANGIOGRAPHY PROCEDURE. DURING THE FIRST INJECTION, WITH THE CATHETER LOCATED IN THE LEFT CORONARY ARTERY, 5 ML OF AIR WAS OBSERVED ON THE FLUOROSCOPIC IMAGES. THE PATIENT SUFFERED A TRANSIENT CARDIAC ARREST BUT WAS REPORTED TO LATER RECOVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1733840 AVANTA FLUID MANAGEMENT SYSTEM ANGIOGRAPHIC INJECTOR DXT BAYER MEDICAL CARE, INC. 60726742 00616258008578

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Hospitalization MULTI-PATIENT STERILE DISPOSABLE SET (MPAT).| SINGLE-PATIENT STERILE DISPOSABLE SET (SPAT).