BEUDAMED
    FDA Adverse Event Death Summary report: N

    AVANTA FLUID MANAGEMENT SYSTEM

    MDR report key: 14027294 · Received April 6, 2022

    Report

    Report Number
    2520313-2022-00013
    Event Type
    Death
    Date Received
    April 6, 2022
    Date of Event
    March 30, 2022
    Report Date
    May 23, 2022
    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 MEDRAD® AVANTA FLUID MANAGEMENT INJECTION SYSTEM (SN (B)(4)) HAS BEEN REQUESTED AND WE ARE AWAITING THE RESULTS. WE HAVE ALSO REQUESTED THE SUBJECT DISPOSABLES THAT WERE INVOLVED WITH THIS INCIDENT. THE EQUIPMENT IS CURRENTLY UNDER QUARANTINE AT THE HOSPITAL. AS WE ARE AWAITING ADDITIONAL INFORMATION, THIS INVESTIGATION REMAINS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    A SYSTEM SERVICE CHECK OF THE MEDRAD® AVANTA FLUID MANAGEMENT INJECTION SYSTEM (SN (B)(6)), COMPLETED ON (B)(6), 2022, CONFIRMED THAT THE INJECTOR WAS OPERATING WITHIN BAYER SPECIFICATIONS. PRODUCT ANALYSIS RECEIVED AND EXAMINED THE RETURNED SALINE PERISTALTIC PUMP FROM THE INJECTOR, AS WELL AS THE MULTI-PATIENT DISPOSABLE SET (MPAT) AND THE SINGLE-PATIENT DISPOSABLE SET (SPAT) THAT WERE IN USE DURING THE PROCEDURE. FUNCTIONAL TESTING CONCLUDED THAT THE RETURNED PRODUCTS PERFORMED TO SPECIFICATION WITH NO PROBLEMS OBSERVED. THE OFFER OF ADDITIONAL CLINICAL APPLICATIONS TRAINING HAS BEEN ACCEPTED BY THE CUSTOMER AND WILL BE SCHEDULED. 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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE FOLLOWING TO BAYER'S DISTRIBUTOR: A PATIENT WAS UNDERGOING A CORONARY ANGIOGRAM WHILE CONNECTED TO THE MEDRAD® AVANTA FLUID MANAGEMENT INJECTION SYSTEM. DURING THE ANGIOPLASTY PORTION OF THE PROCEDURE, THE INJECTOR DISPLAYED MPAT (MULTI-PATIENT STERILE DISPOSABLE SET) ERROR MESSAGES WHICH REQUIRED THE USER TO CONTINUOUSLY DISCONNECT TO PURGE THE INJECTOR SYSTEM. THE EXACT MPAT ERROR MESSAGE FROM THE DISPLAY WAS NOT PROVIDED BY THE CUSTOMER. UPON INSPECTION, THE NURSE NOTICED THAT THE SYRINGE PLUNGER WAS STICKING WHILE FILLING WITH CONTRAST. THE NURSE REPORTED TO THE CARDIOLOGIST THAT THE SYRINGE NEEDED TO BE REPLACED SINCE THE INJECTOR WOULD NOT FUNCTION WITHOUT AN ERROR UNTIL THIS STEP WAS COMPLETED. THE USER PROCEEDED TO CHANGE THE SYRINGE AND FILL IT WITH CONTRAST. DURING THIS PROCESS, THE INJECTOR SYSTEM WAS NOT PURGED AND WAS STILL DISARMED. BEFORE ANY INJECTION OCCURRED, THE PATIENT BECAME UNRESPONSIVE. CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED. A MANUAL INJECTION OF CONTRAST INTO THE LEFT CORONARY SYSTEM REVEALED THAT THE LEFT ANTERIOR DESCENDING AND CIRCUMFLEX ARTERIES WERE TOTALLY OCCLUDED, AND AIR WAS VISUALIZED ON THE DISPLAYED IMAGES. ALTHOUGH CPR WAS ADMINISTERED BY THE MEDICAL TEAM, THE PATIENT COULD NOT BE RESUSCITATED. 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
    1901211 AVANTA FLUID MANAGEMENT SYSTEM ANGIOGRAPHIC INJECTOR DXT BAYER MEDICAL CARE INC. 60764652

    Patients

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