BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANGIOMAT ILLUMENA

    MDR report key: 1622861 · Received March 3, 2010

    Report

    Report Number
    1518293-2010-00026
    Event Type
    Death
    Date Received
    March 3, 2010
    Date of Event
    February 27, 2008
    Report Date
    February 12, 2010
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING INVESTIGATION. UPON RECEIPT OF INVESTIGATION, A MEDWATCH 3500A SUPPLEMENTAL FORM WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON 02/12: (B) (4) LEGAL DEPARTMENT REPORTS VIA PHONE. "WE HAVE BECOME AWARE OF A PATIENT DEATH WITH REGARDS TO AN ILLUMENA INJECTOR SYSTEM. INDICATIONS ARE LACK OF AIR DETECTION DEVICE." LEGAL PROVIDED THE FOLLOWING INFORMATION, (B) (6) AS PERSONAL REPRESENTATIVE OF THE ESTATE OF (B) (6) MD. NO PATIENT PROCEDURAL INFORMATION PROVIDED. ON 02/16: LEGAL PROVIDED THE FOLLOWING; MALE PATIENT UNDERGOING AN ANGIOGRAPHIC PROCEDURE UNDER GENERAL ANESTHESIA. THE OPERATOR OF THE ANGIOMAT INJECTION MACHINE ATTACHED THE MACHINE TO PATIENT SO THAT THE MACHINE COULD INJECT DYE INTO PATIENT'S BLOOD STREAM. THE PHYSICIAN IN CHARGE GAVE THE SIGNAL TO INJECT AND THE OPERATOR PRESSED THE ACTIVATION DEVICE. THE ANGIOMAT INJECTION MACHINE GAVE NO WARNING THAT IT HAD NOT BEEN LOADED WITH DYE AND DID NOT BLOCK ITSELF OR SHUT DOWN. THE ANGIOMAT INJECTION MACHINE INJECTED AIR INTO PATIENT'S BLOOD STREAM. AS A RESULT, PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOMAT ILLUMENA POWER INJECTOR SYSTEM DXT LIEBEL-FLARSHEIM CO. ILLUMENA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death