BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVANTA FLUID MANAGEMENT SYSTEM

    MDR report key: 20136609 · Received September 4, 2024

    Report

    Report Number
    2520313-2024-00017
    Event Type
    Injury
    Date Received
    September 4, 2024
    Date of Event
    August 23, 2024
    Report Date
    October 3, 2024
    Manufacturer
    BAYER MEDICAL CARE INC
    Product Code
    DXT
    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

    THIS INVESTIGATION REMAINS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE AVANTA FLUID MANAGEMENT SYSTEM OPERATION MANUAL CAUTIONS THE USER AS FOLLOWS: "WARNING: EXPEL ALL AIR FROM THE SYRINGE, DRIP CHAMBERS, CONNECTORS, TUBINGS, TRANSDUCER, AND CATHETER BEFORE CONNECTING THE SYSTEM TO THE PATIENT." 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 REPORT OF THE MEDRAD® AVANTA FLUID MANAGEMENT SYSTEM, SERIAL NUMBER (B)(6), COMPLETED (B)(6)2024, VERIFIED IT WAS OPERATING WITHIN BAYER SPECIFICATION. BAYER PRODUCT ANALYSIS RECEIVED AND TESTED THE MEDRAD® MULTI-PATIENT DISPOSABLE SET, LOT NUMBER 232902, AND SINGLE-PATIENT DISPOSABLE SET, LOT NUMBER 231201, IN USE DURING THE PROCEDURE AND CONCLUDED THAT THEY PERFORMED TO SPECIFICATION WITH NO PROBLEMS OBSERVED. THE AVANTA FLUID MANAGEMENT SYSTEM OPERATION MANUAL CAUTIONS THE USER AS FOLLOWS: "WARNING: EXPEL ALL AIR FROM THE SYRINGE, DRIP CHAMBERS, CONNECTORS, TUBINGS, TRANSDUCER, AND CATHETER BEFORE CONNECTING THE SYSTEM TO THE PATIENT." THIS INFORMATION DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, THE COMPANY, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT. NOTE: THE MANUFACTURE DATE FOR THIS DEVICE IS FEBRUARY 1, 2016, WHICH WAS PRIOR TO THE UDI IMPLEMENTATION DATE OF (B)(6) 2016, FOR CLASS II DEVICES. AS SUCH, THIS EQUIPMENT WAS NOT YET REQUIRED TO BEAR UDI MARKING AND/OR REPORTED INTO THE GUDID DATABASE AT THE TIME.

    Description of Event or Problem · 0

    BAYER MEDICAL CARE INC. WAS INFORMED THAT A PATIENT SUFFERED AN ALLEGED AIR INJECTION WHILE CONNECTED TO A MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEM (SN (B)(6). FOLLOWING THE EVENT, THE PATIENT BECAME HYPOTENSIVE, WENT INTO CARDIAC ARREST, AND WAS IMMEDIATELY RESUSCITATED. AN INTRA-AORTIC BALLOON PUMP WAS PLACED, AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

    Description of Event or Problem · 0

    BAYER MEDICAL CARE INC. WAS INFORMED THAT A PATIENT SUFFERED AN ALLEGED AIR INJECTION WHILE CONNECTED TO A MEDRAD® AVANTA FLUID MANAGEMENT INJECTION SYSTEM (SN (B)(6)). FOLLOWING THE EVENT, THE PATIENT BECAME HYPOTENSIVE, WENT INTO CARDIAC ARREST, AND WAS IMMEDIATELY RESUSCITATED. AN INTRA-AORTIC BALLOON PUMP WAS PLACED, AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899013 AVANTA FLUID MANAGEMENT SYSTEM ANGIOGRAPHIC INJECTOR DXT BAYER MEDICAL CARE INC 60726742

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other MULTI-PATIENT DISPOSABLE SET (MPAT).| MULTI-PATIENT DISPOSABLE SET (MPAT).| SINGLE-PATIENT DISPOSABLE SET (SPAT).| SINGLE-PATIENT DISPOSABLE SET (SPAT).