BEUDAMED
    FDA Adverse Event Death Summary report: N

    AVANTA FLUID MANAGEMENT SYSTEM

    MDR report key: 18140558 · Received November 15, 2023

    Report

    Report Number
    2520313-2023-00029
    Event Type
    Death
    Date Received
    November 15, 2023
    Date of Event
    November 2, 2023
    Report Date
    September 25, 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

    ON NOVEMBER 6, 2023 A SYSTEM SERVICE CHECK OF THE MEDRAD® AVANTA FLUID MANAGEMENT SYSTEM (SERIAL NUMBER (B)(6)) VERIFIED THAT IT WAS OPERATING WITHIN BAYER SPECIFICATION. THE MULTI-PATIENT DISPOSABLE SET (MPAT, BATCH NUMBER 224302) AND SINGLE-PATIENT DISPOSABLE SET (SPAT, BATCH NUMBER 224401) THAT WERE IN USE DURING THE INCIDENT ARE BEING HELD BY THE CUSTOMER. BAYER PRODUCT ANALYSIS TESTED RETAINED SAMPLES OF THE MPAT AND SPAT AND CONCLUDED THAT THE RETAINED DISPOSABLES 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.

    Additional Manufacturer Narrative · 0

    A SYSTEM SERVICE CHECK OF THE MEDRAD® AVANTA FLUID MANAGEMENT SYSTEM (SERIAL NUMBER (B)(6) HAS BEEN SCHEDULED. THE MEDRAD® MULTI-PATIENT DISPOSABLE SET (MPAT, LOT NUMBER UNKNOWN) AND SINGLE-PATIENT DISPOSABLE SET (SPAT, LOT NUMBER UNKNOWN) THAT WERE IN USE DURING THE EVENT ARE BEING RETURNED FOR A FULL 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

    ON NOVEMBER 6, 2023 A SYSTEM SERVICE CHECK OF THE MEDRAD® AVANTA FLUID MANAGEMENT SYSTEM (SERIAL NUMBER (B)(6)) VERIFIED THAT IT WAS OPERATING WITHIN BAYER SPECIFICATION. THE MEDRAD® MULTI-PATIENT DISPOSABLE SET (MPAT, LOT NUMBER UNKNOWN) AND SINGLE-PATIENT DISPOSABLE SET (SPAT, LOT NUMBER UNKNOWN) THAT WERE IN USE DURING THE INCIDENT ARE BEING RETAINED BY THE CUSTOMER AND THEREFORE, WILL NOT BE RETURNED FOR EVALUATION. AS THE LOT NUMBERS OF THE ASSOCIATED DISPOSABLES WERE NOT PROVIDED, TESTING OF RETAINED SAMPLES IS NOT POSSIBLE. MULTIPLE DOCUMENTED ATTEMPTS HAVE BEEN MADE TO GAIN SPECIFIC INFORMATION RELATED TO THE REPORTED EVENT; HOWEVER, THOSE ATTEMPTS HAVE BEEN UNSUCCESSFUL. IN THE EVENT THAT ADDITIONAL INFORMATION IS OBTAINED, 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

    THE MANUFACTURE DATE FOR THIS DEVICE IS MAY 1, 2013 WHICH WAS PRIOR TO THE UDI IMPLEMENTATION DATE OF SEPTEMBER 24, 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

    ON (B)(6), 2023, BAYER MEDICAL CARE INC. WAS INFORMED THAT A PATIENT SUFFERED A CARDIAC ARREST DURING A PROCEDURE WHILE CONNECTED TO A MEDRAD® AVANTA FLUID MANAGEMENT SYSTEM (SN (B)(6)). THE MEDICAL STAFF SUSPECTED A POTENTIAL AIR INJECTION; HOWEVER, THIS WAS NOT CONFIRMED. ON (B)(6), 2023, BAYER MEDICAL CARE INC. WAS NOTIFIED THAT THE PATIENT HAD DIED. IT IS UNKNOWN IF AN AUTOPSY HAS BEEN OR WILL BE PERFORMED.

    Description of Event or Problem · 0

    BAYER MEDICAL CARE INC. WAS INFORMED THAT A PATIENT SUFFERED A CARDIAC ARREST DURING A PROCEDURE WHILE CONNECTED TO A MEDRAD® AVANTA FLUID MANAGEMENT SYSTEM (SN (B)(6). THE MEDICAL STAFF SUSPECTED A POTENTIAL AIR INJECTION HOWEVER, THIS WAS NOT CONFIRMED. THE PATIENT WAS HEMODYNAMICALLY STABLE BUT IN A COMA AT THE TIME THE EVENT WAS REPORTED.

    Description of Event or Problem · 0

    ON NOVEMBER 2, 2023 BAYER MEDICAL CARE INC. WAS INFORMED THAT A PATIENT SUFFERED A CARDIAC ARREST DURING A PROCEDURE WHILE CONNECTED TO A MEDRAD® AVANTA FLUID MANAGEMENT SYSTEM (SN (B)(6)). THE MEDICAL STAFF SUSPECTED A POTENTIAL AIR INJECTION HOWEVER, THIS WAS NOT CONFIRMED. NOTE: ON NOVEMBER 20, 2023, BAYER MEDICAL CARE INC. WAS NOTIFIED THAT THE PATIENT HAD SUBSEQUENTLY DIED. IT IS UNKNOWN IF AN AUTOPSY HAS BEEN OR WILL BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298898 AVANTA FLUID MANAGEMENT SYSTEM ANGIOGRAPHIC INJECTOR DXT BAYER MEDICAL CARE INC. 58746413

    Patients

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