BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVANTA FLUID MANAGEMENT SYSTEM

    MDR report key: 7364009 · Received March 22, 2018

    Report

    Report Number
    2520313-2018-00034
    Event Type
    Injury
    Date Received
    March 22, 2018
    Date of Event
    January 22, 2018
    Report Date
    April 11, 2018
    Manufacturer
    BAYER MEDICAL CARE, INC.
    Product Code
    DXT
    PMA / PMN Number
    K050456
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 0

    A SYSTEM SERVICE CHECK OF THE AVANTA FLUID MANAGEMENT SYSTEM, SERIAL NUMBER (B)(4) WAS COMPLETED ON MARCH 6, 2018 WHICH CONFIRMED THAT THE INJECTOR WAS OPERATING WITHIN BAYER SPECIFICATIONS. THE CUSTOMER DID PROVIDE A PHOTOGRAPH OF LOT NUMBER 173303 OF THE SINGLE-PATIENT DISPOSABLE SET (SPAT); HOWEVER, THE ACTUAL PRODUCT USED DURING THIS EVENT WAS NOT RETURNED FOR THE INVESTIGATION. FUNCTIONAL TESTING OF A RETAINED SPAT, LOT NUMBER 173303, AND A LAB STOCK MULTI-PATIENT DISPOSABLE SET (MPAT) CONCLUDED THAT THE 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." THE SITE CONTINUES TO USE THE AVANTA FLUID MANAGEMENT SYSTEM AFTER THE REPORTED EVENT. NO FURTHER ISSUES WERE REPORTED.

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION REMAINS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    AFTER RECEIVING MEDWATCH-(B)(4), BAYER CONTACTED THE CUSTOMER AND RECEIVED THE FOLLOWING CLARIFYING DETAILS ON THIS SUBJECT EVENT: A (B)(6) YEAR OLD FEMALE PATIENT WAS UNDERGOING A LEFT HEART CATHETERIZATION WHILE CONNECTED TO THE AVANTA FLUID MANAGEMENT SYSTEM. AFTER A STENT WAS PLACED WITHIN THE CIRCUMFLEX GRAFT, THE PHYSICIAN NOTICED WHAT WAS DESCRIBED ON THE FOLLOW UP RESPONSES PROVIDED FROM THE CUSTOMER AS "MULTIPLE AIR BUBBLES" ON THE DISPLAYED IMAGES. THE PHYSICIAN USED A PRONTO CATHETER TO SUCCESSFULLY EXTRACT THE AIR. POST AIR REMOVAL, THE PATIENT SUFFERED A V-FIB ARREST WHICH WAS SUCCESSFULLY DEFIBRILLATED INTO A NORMAL SINUS RHYTHM. THE PATIENT WAS THEN TRANSFERRED TO THE ICU FOR FURTHER EVALUATION AND CARE. THE CUSTOMER REPORTED THAT THE PATIENT RECOVERED WITH NO FURTHER COMPLICATIONS OR RESIDUAL EFFECTS. FOLLOW UP RESPONSES FROM THE CUSTOMER ALLEGE THAT THE AIR MAY HAVE ORIGINATED AT THE HUB OF THE COPILOT AND THE MEDRAD TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207269 AVANTA FLUID MANAGEMENT SYSTEM ANGIOGRAPHIC INJECTOR DXT BAYER MEDICAL CARE, INC. 59352532

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R