BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVANTA FLUID MANAGEMENT INJECTION SYSTEM

    MDR report key: 2268885 · Received September 22, 2011

    Report

    Report Number
    2520313-2011-00022
    Event Type
    Injury
    Date Received
    September 22, 2011
    Date of Event
    August 23, 2011
    Report Date
    August 24, 2011
    Manufacturer
    MEDRAD, INC.
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDRAD SERVICE REPRESENTATIVE PERFORMED A SYSTEM SERVICE CHECK OF THE AVANTA FLUID MANAGEMENT INJECTION SYSTEM ON (B)(6) 2011 - THE UNIT WAS FOUND TO BE OPERATING TO MEDRAD SPECIFICATION. BECAUSE THE CUSTOMER ATTRIBUTED THIS TO USER ERROR AND RECOGNIZED THAT THE AIR WAS NOT PROPERLY PURGED FROM THE SYSTEM, THEY DID NOT RETAIN THE DISPOSABLES THAT WERE IN-USE DURING THE REPORTED EVENT; THEREFORE, WE WERE UNABLE TO EVALUATE THE DISPOSABLES. THE EXACT LOT NUMBERS OF THE DISPOSABLES THAT WERE IN-USE DURING THE REPORTED EVENT ARE UNKNOWN; HOWEVER, A SEARCH OF THE CUSTOMER'S SHIPPING RECORDS WERE PERFORMED AND SOME POSSIBLE LOT NUMBERS WERE IDENTIFIED. MEDRAD PRODUCT ANALYSIS EVALUATED RETAINED SAMPLES FROM MULTI-PATIENT DISPOSABLE SET (MPAT) LOT 110904, SINGLE-PATIENT DISPOSABLE SET (SPAT) LOT 111903, AND SYRINGE LOT 110817. VISUAL EXAMINATION FOUND THAT THE SAMPLES WERE IN GOOD OVERALL CONDITION AND THEY WERE FREE OF ANY VISUAL DEFECTS. THE DISPOSABLES WERE INSTALLED ON A TEST AVANTA INJECTOR IN THE LAB. FUNCTIONAL TESTING CONCLUDED THAT THE DISPOSABLES PERFORMED TO SPECIFICATION WITH NO PROBLEMS OBSERVED. A REVIEW OF THE COMPLAINT DATABASE FOUND NO OTHER COMPLAINTS OF THIS NATURE FOR THE REPORTED LOT NUMBERS. THE MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEM OPERATION MANUAL 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. ADDITIONAL APPLICATIONS TRAINING WAS PERFORMED ON (B)(6), 2011.

    Description of Event or Problem · 1

    THE SITE REPORTED THE FOLLOWING: THE STAFF DID NOT END THE PREVIOUS CASE WHEN THEY CHANGED TO THE NEW PATIENT. THE STAFF THEN FAILED TO PURGE THE AIR FROM THE SINGLE-PATIENT DISPOSABLE SET (SPAT) PRIOR TO CONNECTING THE SYSTEM TO THE PATIENT. AN UNKNOWN AMOUNT OF AIR WAS ALLEGEDLY INJECTED INTO THE PATIENT'S RIGHT CORONARY ARTERY. THE PATIENT EXPERIENCED ST ELEVATION AND THE PATIENT'S HEART RATE DECREASED. AN ASPIRATION CATHETER WAS USED TO REMOVE THE AIR FROM THE VESSEL AND A VASOPRESSOR WAS ADMINISTERED. DURING THE STUDY, THE PATIENT RECOVERED. THE PATIENT WAS RELEASED FROM THE HOSPITAL THE DAY AFTER THE PROCEDURE. NOTE THAT THE SITE DID NOT PROVIDE THE PATIENT INFORMATION SUCH AS THE PATIENT'S AGE, SEX, AND WEIGHT.

    Devices

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

    Patients

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