BEUDAMED
    FDA Adverse Event Death Summary report: N

    AVANTA FLUID MANAGEMENT SYSTEM

    MDR report key: 2467582 · Received February 15, 2012

    Report

    Report Number
    2520313-2012-00005
    Event Type
    Death
    Date Received
    February 15, 2012
    Date of Event
    January 23, 2012
    Report Date
    February 1, 2012
    Manufacturer
    MEDRAD
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SITE HAS BEEN OFFERED A SYSTEM SERVICE CHECK OF THE INJECTOR AND WE ARE WAITING FOR THIS TO BE COMPLETED. WHEN THE MEDRAD FIELD SERVICE REPRESENTATIVE CONTACTED THE SITE, IT WAS REPORTED THAT THE INJECTOR IN USE DURING THE ALLEGED AIR INJECTION HAS BEEN USED ON A REGULAR BASIS SINCE THE EVENT WITHOUT INCIDENT. THE SITE DISPOSED OF THE MEDRAD MULTI-PATIENT DISPOSABLE SET (MPAT), THE SINGLE-PATIENT DISPOSABLE SET (SPAT), AND THE SYRINGE THAT WERE ALLEGEDLY IN USE DURING THE REPORTED EVENT BOTH WAS ABLE TO PROVIDE LOT NUMBERS OF THE INVENTORY ON HAND AT THE TIME. MEDRAD QUALITY ASSURANCE PRODUCT ANALYSIS WILL EXAMINE RETAINED SAMPLES FROM THE LOT NUMBERS THE SITE REPORTED TO BE ON HAND IN INVENTORY.

    Description of Event or Problem · 1

    THE SITE REPORTED THE FOLLOWING: "DURING AN ANGIOGRAPHY, THE HEART CATHETERIZATION LAB TEAM DECIDED TO PROCEED WITH AN ANGIOPLASTY. THE MANUAL FILL FUNCTION OF THE AVANTA WAS INITIALIZED, BUT RESULTED IN AN ERROR MESSAGE WHICH WAS UNDERSTOOD TO HAVE RESULTED FROM THE PLUNGER RELEASING FROM THE PISTON. THE SYRINGE WAS REPLACED WITH A NEW ONE; DURING THE SEQUENCE OF STEPS TO ENGAGE THE PISTON WITH THE PLUNGER AND THEN PURGE AIR FROM THE SYRINGE, AIR WAS INJECTED THROUGH THE CATHETER. ATTEMPTS TO RESUSCITATE THE PT WERE ULTIMATELY UNSUCCESSFUL." THE SITE ALSO INDICATED THE PT WAS NOT DISCONNECTED DURING THE REPLACEMENT AND PURGING OF THE SYRINGE.

    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 47 YR Death AVANTA SINGLE-PATIENT DISPOSABLE SET| AVANTA MULTI-PATIENT DISPOSABLE SET