BEUDAMED
    FDA Adverse Event Death Summary report: N

    AVANTA FLUID MANAGEMENT SYSTEM

    MDR report key: 14044532 · Received April 7, 2022

    Report

    Report Number
    2520313-2022-00015
    Event Type
    Death
    Date Received
    April 7, 2022
    Date of Event
    March 24, 2022
    Report Date
    April 20, 2022
    Manufacturer
    BAYER MEDICAL CARE INC.
    Product Code
    DXT
    PMA / PMN Number
    K050456
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 (SN: (B)(6) WAS PERFORMED BY BAYER SERVICE ON MARCH 29, 2022, AT WHICH TIME THE EQUIPMENT WAS CONFIRMED TO BE OPERATING TO SPECIFICATION. BAYER PRODUCT ANALYSIS RECEIVED AND EXAMINED THE RETURNED MULTI-PATIENT DISPOSABLE SET (MPAT), LOT NUMBER: 212902. THE CUSTOMER DID NOT SAVE THE SINGLE-PATIENT DISPOSABLE SET (SPAT) USED DURING THE INCIDENT AND WAS NOT ABLE TO PROVIDE LOT NUMBERS SO THAT RETAINED SAMPLES COULD BE TESTED. FUNCTIONAL TESTING OF THE RETURNED MPAT AND A LAB STOCK SINGLE-PATIENT DISPOSABLE SET (SPAT) CONCLUDED THAT THE DISPOSABLES PERFORMED TO SPECIFICATION WITH NO PROBLEMS OBSERVED. THE MEDRAD® AVANTA FLUID MANAGEMENT INJECTION 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." THE OFFER OF ADDITIONAL CLINICAL APPLICATIONS TRAINING WAS DECLINED BY THE CUSTOMER. THE SITE CONTINUES TO USE THE MEDRAD® AVANTA FLUID MANAGEMENT INJECTION SYSTEM AFTER THE REPORTED EVENT WITH NO FURTHER ISSUES REPORTED. 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 MEDRAD® AVANTA FLUID MANAGEMENT INJECTOR SYSTEM (SN (B)(4)), WAS PERFORMED, BY BAYER SERVICE ON (B)(6) 2022, AT WHICH TIME THE EQUIPMENT WAS CONFIRMED TO BE OPERATING TO SPECIFICATION. AS WE ARE AWAITING ADDITIONAL INFORMATION, THIS INVESTIGATION REMAINS IN PROGRESS. 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.

    Description of Event or Problem · 0

    ON APRIL 13, 2022, BAYER MEDICAL CARE RECEIVED ADDITIONAL PROCEDURE RELATED INFORMATION SURROUNDING THE ALLEGED PATIENT DEATH. WE HAVE UPDATED THE DESCRIPTION OF THE EVENT AS FOLLOWS: A 59-YEAR OLD MALE PATIENT WAS UNDERGOING A CORONARY ANGIOGRAPHY PROCEDURE FOR AN ACUTE MYOCARDIAL INFARCTION AND WAS CONNECTED TO A MEDRAD® AVANTA FLUID MANAGEMENT INJECTION SYSTEM. DURING THE FIRST CONTRAST INJECTION, THE PATIENT COMPLAINED OF "GREAT CHEST PAIN WITH SUSTAINED ST-SEGMENT SHIFT AND HEMODYNAMIC INSTABILITY." THE CUSTOMER SUSPECTED EITHER THROMBUS MIGRATION OR INTRACORONARY INJECTION OF AIR, NEITHER OF WHICH WERE CONFIRMED. LAVAGE OF THE ARTERY AND AN INTRACORONARY INJECTION OF ADENOSINE WAS PERFORMED WITHOUT EFFECT AND THE PHYSICIAN INITIATED EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) AFTER WHICH THE PATIENT WAS TRANSFERRED TO THE ICU. THE CUSTOMER REPORTED THAT THE PATIENT SUFFERED MULTIORGAN FAILURE SYNDROME AND DIED A FEW HOURS LATER. THE CUSTOMER ALSO REPORTED THAT AUTOPSY RESULTS WILL NOT BE PROVIDED TO BAYER MEDICAL CARE. CORRECTED DATA FROM INITIAL 3500A REPORT: THE INITIAL MDR (2520313-2022-00015) DATED APRIL 7, 2022, WAS SUBMITTED WITH AN INCORRECT "DATE OF EVENT" AND SERIAL NUMBER OF THE INJECTOR. THE ORIGINAL INFORMATION PROVIDED BY THE CUSTOMER WAS LATER DETERMINED TO BE INCORRECT. THE ACTUAL DATE OF THE EVENT WAS MARCH 24, 2022. THE CORRECT SERIAL NUMBER INVOLVED WITH THIS EVENT IS (B)(6).

    Description of Event or Problem · 0

    ON (B)(6) 2022, BAYER SERVICE IN (B)(6) PERFORMED AN INJECTOR CHECKOUT AFTER RECEIVING A CALL FROM THE CUSTOMER THAT A PATIENT DEATH OCCURRED WHILE USING THE MEDRAD® AVANTA FLUID MANAGEMENT INJECTOR SYSTEM. THE CUSTOMER ALLEGED THAT AIR WAS INJECTED WHILE THE PATIENT WAS CONNECTED TO THE MEDRAD® AVANTA FLUID MANAGEMENT INJECTOR SYSTEM. THE EXACT AMOUNT AND ANATOMICAL LOCATION OF THE ALLEGED AIR WAS NOT DISCLOSED. WE HAVE REQUESTED ADDITIONAL INFORMATION FROM THE CUSTOMER, INCLUDING AN AUTOPSY STATEMENT. HOWEVER, NO ADDITIONAL DETAILS HAVE BEEN PROVIDED TO BAYER MEDICAL CARE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810331 AVANTA FLUID MANAGEMENT SYSTEM ANGIOGRAPHIC INJECTOR DXT BAYER MEDICAL CARE INC. 58746413

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Death MULTI-PATIENT DISPOSABLE SET (MPAT).| MULTI-PATIENT STERILE DISPOSABLE SET (MAPT).| SINGLE-PATIENT DISPOSABLE SET (SPAT).| SINGLE-PATIENT STERILE DISPOSABLE SET (SPAT).