BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDRAD ANGIOGRAPHIC INJECTOR

    MDR report key: 1406192 · Received June 20, 2009

    Report

    Report Number
    2520313-2009-00024
    Event Type
    Death
    Date Received
    June 20, 2009
    Date of Event
    May 22, 2009
    Report Date
    June 19, 2009
    Manufacturer
    MEDRAD, INC.
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDRAD INTERVENTIONAL REP WAS ASKED TO VISUALLY INSPECT THE SYSTEM AND THE DISPOSABLES AT THE SITE (THE SET-UP WAS STILL INTACT) TO DETERMINE WHETHER THE SYSTEM WAS SET-UP CORRECTLY. BASED ON THIS VISUAL INSPECTION, THE DISPOSABLES WERE SET-UP CORRECTLY. HOWEVER, AS THE MEDRAD REP NOTED TO THE SITE, PROPER PURGING CANNOT BE CONFIRMED AFTER A PROCEDURE HAS BEEN COMPLETED. IT WAS REPORTED THAT A PHYSICIAN, ALONG WITH OTHER STAFF MEMBERS AT THE HOSPITAL, INDICATED THAT THEY BELIEVE THAT THE SINGLE PATIENT DISPOSABLE SET (SPAT) WAS NOT PROPERLY PURGED OF AIR PRIOR TO THE FIRST INJECTION. SUBSEQUENTLY, A MEDRAD SERVICE ENGINEER PERFORMED A SYSTEM CHECKOUT. NO ISSUES WERE FOUND. THE SITE RETAINED THE DISPOSABLES THAT WERE IN USE DURING THE PROCEDURE. MEDRAD IS AWAITING A DECISION FROM THE HOSPITAL AS TO WHETHER THEY WILL BE RELEASING THE DISPOSABLES TO MEDRAD FOR EVAL. ADD'L APPLICATIONS TRAINING WAS OFFERED TO THE SITE. NO RESPONSE HAS BEEN RECEIVED FROM THE CUSTOMER.

    Description of Event or Problem · 1

    THE PT WAS SCHEDULED FOR A DIAGNOSTIC LEFT HEART CATHETERIZATION. AN AIR INJECTION OF AN UNSPECIFIED AMOUNT OF AIR REPORTEDLY OCCURRED AND INTERVENTIONAL WIRES WERE INTRODUCED. THE PT SUBSEQUENTLY EXPIRED. MULTIPLE ATTEMPTS TO GATHER INFO FROM HOSPITAL HAVE BEEN MADE. INFO REQUESTED INCLUDED: QUANTITY OF AIR NOTED, SEQUENCE OF EVENTS, AUTOPSY STATUS, AND PT WEIGHT. DESPITE REPEATED ATTEMPTS, THE HOSPITAL HAS NOT RELEASED THE REQUESTED INFO.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Death