BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVANTA FLUID MANAGEMENT INJECTION SYSTEM

    MDR report key: 1873623 · Received October 13, 2010

    Report

    Report Number
    2520313-2010-00031
    Event Type
    Injury
    Date Received
    October 13, 2010
    Date of Event
    September 13, 2010
    Report Date
    October 13, 2010
    Manufacturer
    MEDRAD
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SYSTEM SERVICE CHECK, ON SEPTEMBER 13TH, OF THE AVANTA INJECTOR VERIFIED THE INJECTOR IS WORKING WITHIN MEDRAD SPECIFICATIONS. THE SITE INDICATED THAT THEY DID NOT RETAIN THE DISPOSABLES THAT WERE IN-USE DURING THE REPORTED EVENT. THE BATCH NUMBERS WERE NOT PROVIDED FOR THE DISPOSABLES; THEREFORE, NO FURTHER INVESTIGATION IS POSSIBLE. THE SUPERVISOR ALSO STATED THAT HE BELIEVES THE AIR WAS INTRODUCED FROM THE SINGLE-PATIENT DISPOSABLE SET NOT BEING PROPERLY PRIMED PRIOR TO CONNECTION TO THE PATIENT. ADDITIONAL APPLICATIONS TRAINING IS SCHEDULED FOR OCTOBER 13, 2010. THE MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEM OPERATION MANUAL (B)(4) STATES THE FOLLOWING: "DO NOT CONNECT A PATIENT TO THE INJECTOR, OR ATTEMPT AN INJECTION UNTIL ALL TRAPPED AIR HAS BEEN CLEARED FROM THE SYRINGE AND FLUID PATH. EXPEL ALL TRAPPED AIR FROM THE SYRINGE, DRIP CHAMBERS, CONNECTORS, TUBINGS, AND CATHETER BEFORE CONNECTING THE SYSTEM TO THE PATIENT. CAREFULLY READ THE INSTRUCTIONS FOR LOADING AND THE USE OF FLUIDOT INDICATORS (WHERE APPLICABLE) TO REDUCE THE CHANCE OF AIR EMBOLISM."

    Description of Event or Problem · 1

    THE SITE REPORTED THE FOLLOWING: THE PATIENT WAS SCHEDULED FOR A DIAGNOSTIC CARDIAC CATHETERIZATION. AN ANGIOGRAM OF THE RIGHT CORONARY ARTERY WAS PERFORMED AND THE TECHNOLOGIST STATES APPROXIMATELY 1-2CCS OF AIR WAS OBSERVED ON THE ANGIOGRAM. THE CARDIAC CATHETERIZATION LAB SUPERVISOR REPORTED THAT THE PATIENT COMPLAINED OF CHEST PAIN; ST SEGMENT ELEVATION WAS NOTED ON THE ECG MONITOR. THE SUPERVISOR ESTIMATES THE PATIENT RECEIVED 100-200MCGS OF INTRACORONARY ADENOSINE. THE PATIENT'S CHEST PAIN RESOLVED AND THE ST SEGMENT ELEVATION PREVIOUSLY NOTED RETURNED TO BASELINE. THE PATIENT WAS DISCHARGED WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVANTA FLUID MANAGEMENT INJECTION SYSTEM ANGIOGRAPHIC INJECTOR DXT MEDRAD AVA 500 PEDL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention AVANTA SINGLE-PATIENT DISPOSABLE SET| AVANTA MULTI-PATIENT DISPOSABLE SET