BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVANTA FLUID MANAGEMENT INJECTION SYSTEM

    MDR report key: 2162146 · Received July 7, 2011

    Report

    Report Number
    2520313-2011-00018
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    MEDRAD
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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), 2011 AND THE UNIT WAS FOUND TO BE OPERATING TO SPECIFICATION. THE SITE CONTINUED TO USE THE INJECTOR AFTER THE REPORTED EVENT - NO FURTHER ISSUES WERE REPORTED. MEDRAD QUALITY ASSURANCE PRODUCT ANALYSIS EXAMINED THE PRODUCTS THAT WERE RETURNED BY THE SITE, WHICH CONSISTED OF THE FOLLOWING: ONE MULTI-PATIENT DISPOSABLE SET (MPAT) WITH A 500ML BAG OF HEPARIN ATTACHED TO THE SALINE SIDE, ONE SINGLE-PATIENT DISPOSABLE SET (SPAT) WITH A NON-MEDRAD HEMODYNAMIC TRANSDUCER ATTACHED, A HAND CONTROLLER, AND A SYRINGE. FUNCTIONAL TESTING OF THE RETURNED PRODUCTS CONFIRMED THAT THE DISPOSABLES PERFORMED TO SPECIFICATION WITH NO PROBLEMS FOUND. ADDITIONAL APPLICATIONS TRAINING WAS OFFERED TO THE SITE; HOWEVER, THEY DECLINED.

    Description of Event or Problem · 1

    THE SITE REPORTED THE FOLLOWING: A PATIENT WITH AN ADMITTING DIAGNOSIS OF A POSITIVE STRESS TEST UNDERWENT A DIAGNOSTIC CARDIAC CATHETERIZATION. FOLLOWING THE FIRST INJECTION, AIR WAS VISUALIZED IN THE LEFT ANTERIOR DESCENDING ARTERY. THE AMOUNT OF AIR THAT WAS INJECTED INTO THE PATIENT IS UNKNOWN. ST SEGMENT ELEVATION WAS NOTED ON THE ECG MONITOR. THE PATIENT REQUIRED MEDICAL INTERVENTION, WHICH INCLUDED ATROPINE, EPINEPHRINE AND AN INSERTION OF AN INTRA-AORTIC BALLOON PUMP. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT AND DISCHARGED TO HOME LATER THAT WEEK. THE PATIENT IS REPORTEDLY DOING WELL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention AVANTA SINGLE-PATIENT DISPOSABLE SET| AVANTA MULTI-PATIENT DISPOSABLE SET