BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACIST

    MDR report key: 2830545 · Received November 5, 2012

    Report

    Report Number
    2134243-2012-00015
    Event Type
    Death
    Date Received
    November 5, 2012
    Date of Event
    October 3, 2012
    Report Date
    November 5, 2012
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    PMA / PMN Number
    K991103
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACIST ANGIOGRAPHIC CONTRAST INJECTION SYSTEM, MODEL CVI, AND CONSUMABLES KITS USED DURING THIS EVENT WERE REQUESTED TO BE RETURNED TO ACIST FOR TESTING. A COPY OF THE CINE-ANGIOGRAM WAS ALSO REQUESTED, BUT THE USER FACILITY ELECTED NOT TO PROVIDE THIS INFORMATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE USER FACILITY REGARDING THIS EVENT. UPON COMPLETION OF TESTING, A FOLLOW-UP REPORT WILL BE SUBMITTED TO FDA.

    Description of Event or Problem · 1

    NARRATIVE: USER FACILITY REPORTED THAT DURING AN ANGIOGRAPHY, A PATIENT EXPIRED. AIR WAS INJECTED UPON THE FIRST INJECTION OF CONTRAST MEDIA. THE USER FACILITY REPORTED THAT THE CAUSE OF THE EVENT WAS MOST LIKELY DUE TO USER ERROR. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACIST ANGIOGRAPHIC INJECTION SYSTEM DXT ACIST MEDICAL SYSTEMS, INC. CVI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death