BEUDAMED
    FDA Adverse Event Death Summary report: N

    AVANTA FLUID MANAGEMENT SYSTEM

    MDR report key: 12703606 · Received October 27, 2021

    Report

    Report Number
    2520313-2021-00039
    Event Type
    Death
    Date Received
    October 27, 2021
    Date of Event
    October 19, 2021
    Report Date
    December 9, 2021
    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 THE AVANTA FLUID MANAGEMENT SYSTEM, SERIAL NUMBER (B)(6), WAS COMPLETED ON (B)(6) 2021 WHICH CONFIRMED THAT THE INJECTOR WAS OPERATING WITHIN BAYER SPECIFICATIONS. BAYER PRODUCT ANALYSIS RECEIVED AND EXAMINED THE RETURNED SYRINGE, MULTI-PATIENT DISPOSABLE SET (MPAT) AND SINGLE-PATIENT DISPOSABLE SET (SPAT) THAT WAS USED DURING THE PROCEDURE. FUNCTIONAL TESTING CONCLUDED THAT THE RETURNED PRODUCTS PERFORMED TO SPECIFICATION WITH NO PROBLEMS OBSERVED. THE OFFER OF ADDITIONAL CLINICAL APPLICATIONS TRAINING WAS DECLINED BY THE CUSTOMER. 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 · 1

    A SYSTEM SERVICE CHECK OF THE AVANTA FLUID MANAGEMENT SYSTEM SERIAL NUMBER (B)(4) HAS BEEN REQUESTED AND WE ARE AWAITING THE RESULTS. 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." THE DISPOSABLES 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.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED TO BAYER. A 69 YEAR OLD MALE PATIENT WAS UNDERGOING A CORONARY ANGIOGRAM FOR A NON-ST ELEVATION MYOCARDIAL INFARCTION (NON-STEMI) WHILE CONNECTED TO AN AVANTA FLUID MANAGEMENT SYSTEM. A FEMORAL APPROACH WAS UTILIZED TO INJECT CONTRAST INTO THE LEFT CORONARY ARTERY. DURING THE PROCEDURE, THE RADIOGRAPHER EXCHANGED THE MULTI-PATIENT DISPOSABLE SET (MPAT) SYRINGE. THE RADIOGRAPHER REPORTED THE FOLLOWING TO BAYER, "PATIENT CRASHED WHILE I WAS FILLING SYRINGE ONLY TO REALIZE THAT THERE WAS AIR IN THE SYSTEM". THE CUSTOMER REPORTED THAT THE PATIENT BEGAN TO "GROAN" FOLLOWED BY A DECLINE IN THE PULSE AND BLOOD PRESSURE. SCREENING WAS DONE IMMEDIATELY AT WHICH TIME LARGE AIR BUBBLES WERE VISUALIZED ON THE CATHETER THAT WAS LOCATED WITHIN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. CARDIOPULMONARY RESUSCITATION (CPR) WAS ADMINISTERED BY THE MEDICAL TEAM, BUT THE PATIENT COULD NOT BE RESUSCITATED. THE CUSTOMER CONCLUDED THAT THE PATIENT'S DEATH WAS DUE TO A MASSIVE ANTERIOR MYOCARDIAL INFARCTION (MI) RELATED TO AIR BEING INTRODUCED INTO THE LAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1603630 AVANTA FLUID MANAGEMENT SYSTEM ANGIOGRAPHIC INJECTOR DXT BAYER MEDICAL CARE INC. 58746413

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Death MX-AVA500 HC - LOT: 193505| MX-AVA500 HCS - LOT: D192011| MX-AVA500 MPAT - LOT: 204102 & 8411234| MX-AVA500 SPATL - LOT: 201401| MX-AVA500 HC - LOT: 193505| MX-AVA500 HCS - LOT: D192011| MX-AVA500 MPAT - LOT: 204102 & 8411234| MX-AVA500 SPATL - LOT: 201401