BEUDAMED
    FDA Adverse Event Death Summary report: N

    AVANTA FLUID MANAGEMENT SYSTEM

    MDR report key: 19118267 · Received April 16, 2024

    Report

    Report Number
    2520313-2024-00008
    Event Type
    Death
    Date Received
    April 16, 2024
    Report Date
    September 25, 2024
    Manufacturer
    BAYER MEDICAL CARE INC.
    Product Code
    DXT
    UDI-DI
    00616258021447
    PMA / PMN Number
    K050456
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SYSTEM SERVICE CHECK OF THE MEDRAD® AVANTA FLUID MANAGEMENT INJECTION SYSTEM, SERIAL NUMBER (B)(6), WAS PERFORMED ON (B)(6) 2024, WHICH CONFIRMED THAT THE INJECTOR WAS OPERATING WITHIN BAYER SPECIFICATIONS. THE MEDRAD® SPAT AND THE MULTI-PATIENT DISPOSABLE SET (MPAT) IN USE DURING THE INCIDENT WERE NOT SAVED. LOT NUMBERS FOR THE SUBJECT DISPOSABLES WERE NOT PROVIDED; THEREFORE, TESTING OF RETAINED SAMPLES IS NOT POSSIBLE. ADDITIONAL APPLICATIONS TRAINING WAS PROVIDED BY THE BAYER CLINICAL PERFORMANCE TEAM. IN REGARD TO THE ALLEGATION OF A DAMPENED WAVEFORM, NO FURTHER INVESTIGATION WAS POSSIBLE WITHOUT RETURNED DISPOSABLE SETS OR IDENTIFICATION OF LOT NUMBERS. 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

    UDI RELATED DATA QUALITY UPDATES ONLY. CORRECTION: FOR UDI DATA DISCREPANCY/MISMATCH ON PREVIOUSLY SUBMITTED MDR AND TO ENSURE THE DEVICE IDENTIFICATION DATA IS IN ALIGNMENT WITH GUDID.

    Additional Manufacturer Narrative · 0

    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 10, 2024, BAYER MEDICAL CARE INC. WAS NOTIFIED OF A PATIENT DEATH THAT OCCURRED IN (B)(6) OF 2024 WHILE THE PATIENT WAS CONNECTED TO A MEDRAD® AVANTA FLUID MANAGEMENT INJECTION SYSTEM (SN (B)(6)) DURING A RIGHT-HEART CATHETERIZATION TO DETERMINE SUITABILITY FOR A TRICUSPID VALVE REPLACEMENT. AT AN UNSPECIFIED POINT DURING THE STUDY, THE PATIENT SUDDENLY BECAME UNSTABLE DUE TO UNKNOWN CLINICAL FACTORS. THE DETAILS OF ANY MEDICAL INTERVENTION UNDERTAKEN LEADING UP TO THE PATIENT'S DEATH ARE UNKNOWN, DESPITE MULTIPLE ATTEMPTS TO GAIN THIS INFORMATION. BAYER MEDICAL CARE INC. HAS NOT RECEIVED AN AUTOPSY REPORT AND/OR CAUSE OF DEATH STATEMENT. ALTHOUGH UNRELATED TO THE PATIENT EVENT ABOVE, THE HOSPITAL STAFF FURTHER COMMUNICATED THAT DURING THE PROCEDURE, THE HEMODYNAMIC WAVEFORM, AS MEASURED BY A THIRD PARTY'S PRESSURE TRANSDUCER CONNECTED TO THE MEDRAD® SINGLE PATIENT DISPOSABLE SET (SPAT) HAD DAMPENED.

    Description of Event or Problem · 0

    ON APRIL 10, 2024, BAYER MEDICAL CARE INC. WAS NOTIFIED THAT A PATIENT HAD DIED IN (B)(6) 2024 DURING A RIGHT-HEART CATHETERIZATION PROCEDURE WHILE CONNECTED TO A MEDRAD® AVANTA FLUID MANAGEMENT INJECTION SYSTEM (SERIAL NUMBER UNKNOWN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690796 AVANTA FLUID MANAGEMENT SYSTEM ANGIOGRAPHIC INJECTOR DXT BAYER MEDICAL CARE INC. 86600129 00616258021447

    Patients

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