BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVANTA FLUID MANAGEMENT SYSTEM

    MDR report key: 2534357 · Received April 9, 2012

    Report

    Report Number
    2520313-2012-00015
    Event Type
    Injury
    Date Received
    April 9, 2012
    Date of Event
    March 15, 2012
    Report Date
    March 15, 2012
    Manufacturer
    MEDRAD
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDRAD SERVICE ENGINEER PERFORMED A SYSTEM SERVICE CHECK OF THE AVANTA FLUID MANAGEMENT INJECTION SYSTEM ON (B)(4) 2012 AND THE UNIT WAS FOUND TO BE OPERATING TO SPECIFICATION. THE SITE INDICATED THAT THERE WERE NO ERROR MESSAGES ON THE INJECTOR AT THE TIME OF THE REPORTED INCIDENT. THE SITE HAD MENTIONED TO A MEDRAD REP THAT THIS REPORTED INCIDENT MAY HAVE BEEN DUE TO USER ERROR. THE SITE CONTINUES TO USE THE INJECTOR AFTER THE REPORTED EVENT - NO FURTHER ISSUES WERE REPORTED. THE SITE DID NOT DISCLOSE THE LOT NUMBER FOR THE MULTI-PATIENT DISPOSABLE SET (MPAT) THAT WAS IN USE DURING THE REPORTED ISSUE. THE SINGLE-PATIENT DISPOSABLE SET (SPAT) THAT WAS IN USE DURING THIS ISSUE WAS IDENTIFIED AS LOT NUMBER 113802; HOWEVER THE SITE WOULD NOT RELEASE THE DISPOSABLE FOR EVAL. MEDRAD QUALITY ASSURANCE PRODUCT ANALYSIS EXAMINED A RETAINED SPAT SAMPLE FROM LOT NUMBER 113802. NO VISUAL OR FUNCTIONAL DEFECTS WERE IDENTIFIED - THE PRODUCT PERFORMED TO MEDRAD SPECIFICATION. ADDITIONAL APPLICATIONS TRAINING WAS PROVIDED ON (B)(4) 2012. FURTHER FOLLOW UP TRAINING IS SCHEDULED ON (B)(4) 2012.

    Description of Event or Problem · 1

    THE SITE REPORTED THE FOLLOWING: A PT WITH AN EXTENSIVE MEDICAL HISTORY AND AN ADMITTING DIAGNOSIS OF SHORTNESS OF BREATH UNDERWENT AND LEFT CARDIAC CATHETERIZATION WITH MYOCARDIAL BIOPSY TO SCREEN FOR HEMOCHROMATOSIS. PRIOR TO THE INTRODUCTION OF A PRESSURE WIRE, A DIAGNOSTIC IMAGE WAS PERFORMED USING THE AVANTA INJECTOR. AIR WAS VISUALIZED FOLLOWING THE INTRODUCTION OF THE PRESSURE WIRE INTO THE CORONARY ARTERY. THE PT'S VITAL SIGNS BEGAN TO DECLINE. THE PT REQUIRED MEDICAL INTERVENTION, WHICH INCLUDED INTUBATION FOLLOWED BY AN INSERTION OF AN INTRA-AORTIC BALLOON PUMP. THE PT WAS ADMITTED TO THE INTENSIVE CARE UNIT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R AVANTA MULTI-PATIENT DISPOSABLE SET (MPAT)| AVANTA SINGLE-PATIENT DISPOSABLE SET (SPAT)