BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVANTA FLUID MANAGEMENT SYSTEM

    MDR report key: 19614050 · Received June 26, 2024

    Report

    Report Number
    2520313-2024-00012
    Event Type
    Injury
    Date Received
    June 26, 2024
    Date of Event
    June 7, 2024
    Report Date
    July 29, 2024
    Manufacturer
    BAYER MEDICAL CARE INC.
    Product Code
    DXT
    PMA / PMN Number
    K050456
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SYSTEM SERVICE CHECK OF MEDRAD® AVANTA FLUID MANAGEMENT INJECTION SYSTEM (SERIAL NUMBER (B)(6)) HAS BEEN REQUESTED AND WE ARE AWAITING THE RESULTS. THE DISPOSABLES THAT WERE IN USE DURING THE EVENT ARE BEING RETURNED FOR EVALUATION. ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS INFORMATION DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, THE COMPANY, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT.

    Additional Manufacturer Narrative · 0

    A SYSTEM SERVICE CHECK OF THE MEDRAD® AVANTA FLUID MANAGEMENT SYSTEM, SERIAL NUMBER: (B)(6), WAS COMPLETED ON JUNE 11, 2024 WHICH CONFIRMED THAT THE INJECTOR WAS OPERATING WITHIN BAYER SPECIFICATIONS. BAYER PRODUCT ANALYSIS RECEIVED AND EXAMINED THE RETURNED MULTI-PATIENT STERILE DISPOSABLE SET (MPAT, LOT NUMBER: 231304) AND MPAT SYRINGE (LOT NUMBER: 8421646). FUNCTIONAL TESTING OF THE RETURNED PRODUCTS AND A RETAINED SINGLE-PATIENT STERILE DISPOSABLE SET (SPAT, LOT NUMBER: 230701) CONFIRMED THE PRODUCTS PERFORMED TO SPECIFICATION WITH NO PROBLEMS OBSERVED. THE MEDRAD® AVANTA FLUID MANAGEMENT INJECTION SYSTEM OPERATION MANUAL CAUTIONS THE USER AS FOLLOWS: DO NOT CONNECT A PATIENT TO THE INJECTOR OR ATTEMPT AN INJECTION UNTIL ALL AIR HAS BEEN REMOVED FROM THE SYRINGE AND FLUID PATH. EXPEL ALL AIR FROM THE SYRINGE, DRIP CHAMBERS, CONNECTORS, TUBINGS, TRANSDUCER, AND CATHETER BEFORE CONNECTING THE SYSTEM TO THE PATIENT. BEFORE CONNECTING THE SINGLE-PATIENT DISPOSABLE SET (SPAT) TO THE PATIENT, ENSURE ALL STOPCOCKS AND OPEN PORTS ARE CLOSED TO AIR AND ALL AIR HAS BEEN REMOVED FROM THE FLUID PATH BEFORE INJECTION. IMPROPER MANIPULATION OF THE WASTE PORT STOPCOCK AS WELL AS ANY FLUID PORT LEFT OPEN TO AIR MAY INCREASE THE RISK OF INTRODUCING AIR INTO THE FLUID PATH. DO NOT ATTEMPT TO ASPIRATE FLUID FROM THE HEMODYNAMIC PORT. DOING SO MAY INCREASE THE RISK OF INDUCING AIR INTO THE FLUID PATH. VERIFY THAT THE FLUID PATH IS OPEN AND FREE OF AIR BEFORE ATTEMPTING AN INJECTION. MULTIPLE DOCUMENTED ATTEMPTS HAVE BEEN MADE TO GAIN SPECIFIC INFORMATION RELATED TO THE REPORTED EVENT; HOWEVER, THE CUSTOMER HAS DECLINED TO PROVIDE ANY DETAILS. THE SITE CONTINUES TO USE THE MEDRAD® AVANTA FLUID MANAGEMENT INJECTION SYSTEM AFTER THE REPORTED EVENT. NO FURTHER ISSUES WERE REPORTED. 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 THE FOLLOWING TO BAYER'S DISTRIBUTOR: A PATIENT WAS UNDERGOING AN INTERVENTIONAL ANGIOGRAM WHILE CONNECTED TO THE MEDRAD® AVANTA FLUID MANAGEMENT INJECTION SYSTEM (SERIAL NUMBER (B)(6)). DURING THE PROCEDURE, AN UNDISCLOSED AMOUNT OF AIR WAS ALLEGEDLY VISUALIZED WITHIN THE RIGHT CORONARY ARTERY ON THE DISPLAYED IMAGES. BAYER IS ATTEMPTING TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS INCIDENT. THE PATIENT IS REPORTED TO BE DOING WELL WITH NO FURTHER ISSUES REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE FOLLOWING TO BAYER'S DISTRIBUTOR: A PATIENT WAS UNDERGOING AN INTERVENTIONAL ANGIOGRAM WHILE CONNECTED TO THE MEDRAD® AVANTA FLUID MANAGEMENT INJECTION SYSTEM (SERIAL NUMBER: (B)(6). DURING THE PROCEDURE, AN UNDISCLOSED AMOUNT OF AIR WAS ALLEGEDLY VISUALIZED WITHIN THE RIGHT CORONARY ARTERY ON THE DISPLAYED IMAGES. THE PATIENT IS REPORTED TO BE DOING WELL WITH NO FURTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689118 AVANTA FLUID MANAGEMENT SYSTEM ANGIOGRAPHIC INJECTOR DXT BAYER MEDICAL CARE INC. 58746413

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Unknown Other HAND CONTROLLER - LOT 224705| HAND CONTROLLER - LOT 224705.| MPAT - LOT 231304.| MPAT - LOT 231304.| MPAT SYRINGE - LOT 8421646.| SPAT - LOT 230701| SPAT - LOT 230701.