BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVANTA FLUID MANAGEMENT SYSTEM

    MDR report key: 2428586 · Received January 20, 2012

    Report

    Report Number
    2520313-2012-00002
    Event Type
    Injury
    Date Received
    January 20, 2012
    Date of Event
    December 23, 2011
    Report Date
    December 27, 2011
    Manufacturer
    MEDRAD
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 ONSITE BIOMEDICAL ENGINEER CONVERSED WITH THE MEDRAD SERVICE REPRESENTATIVE AT THE TIME OF THE INJECTOR CHECKOUT AND STATED THAT HE BELIEVED THE INJECTOR DID NOT CONTRIBUTE TO THE REPORTED INCIDENT. THE SITE DECOMMISSIONED THE INJECTOR AFTER THE REPORTED EVENT AND PLACED IT BACK INTO COMMISSION ON(B)(4) 2012. THE SITE DISPOSED OF THE MEDRAD SINGLE-PATIENT DISPOSABLE SET (SPAT) THAT WAS IN USE AT THE TIME OF THE REPORTED EVENT BUT WAS ABLE TO PROVIDE LOT NUMBERS OF THE INVENTORY ON HAND AT THE TIME. THE SITE HAS RETAINED THE MEDRAD MULTI-PATIENT DISPOSABLE SET (MPAT) THAT WAS IN USE. MEDRAD QUALITY ASSURANCE PRODUCT ANALYSIS EXAMINED RETAINED SPAT SAMPLES FROM THE LOT NUMBERS THE SITE REPORTED TO BE ON HAND IN INVENTORY. IN ADDITION, AN UN-USED MPAT, LOT NUMBER 113403 FROM THE CUSTOMER'S INVENTORY ON HAND WAS RETURNED AND EVALUATED. NO VISUAL OR FUNCTIONAL DEFECTS WERE IDENTIFIED - ALL PRODUCT PERFORMED TO MEDRAD SPECIFICATION. ADDITIONAL APPLICATIONS TRAINING WAS PROVIDED TO THE STAFF ON (B)(4) 2012. FURTHER ADDITIONAL APPLICATIONS TRAINING, REQUESTED BY THE PHYSICIANS AT THE SITE, WILL BE PERFORMED ON (B)(4) 2012.

    Description of Event or Problem · 1

    THE SITE REPORTED THE FOLLOWING: A PATIENT WITH AN ADMITTING DIAGNOSIS OF ST SEGMENT ELEVATION WITH MYOCARDIAL INFARCTION (STEM) UNDERWENT AN EMERGENT CARDIAC CATHETERIZATION. DURING THE PROCEDURE, FOLLOWING THE FIRST INJECTION, THE PATIENT RECEIVED NON-DISCLOSED MEDICAL INTERVENTION DUE TO EITHER AN AIR INJECTION OR A THROMBUS WHICH OCCURRED IN THE LEFT CORONARY ARTERY - THE STAFF PHYSICIAN WAS UNABLE TO CONCLUDE WHETHER THIS WAS A THROMBUS OR AN AIR INJECTION. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT AND WAS DISCHARGED TO HOME LATER THAT WEEK. THE PATIENT WAS REPORTEDLY DOING WELL.

    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 31 YR Required Intervention AVANTA SINGLE-PATIENT DISPOSABLE SET| AVANTA MULTI-PATIENT DISPOSABLE SET