BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACIST

    MDR report key: 3319927 · Received August 1, 2013

    Report

    Report Number
    2134243-2013-00007
    Event Type
    Malfunction
    Date Received
    August 1, 2013
    Date of Event
    July 7, 2013
    Report Date
    August 1, 2013
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    PMA / PMN Number
    K06302
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL INCLUDE THE SUMMARY OF THE DEVICE EVALUATION. IN THE OPINION OF ACIST'S MEDICAL ADVISORY BOARD MEMBER, THIS INCIDENT IS LOOKED AT AS A FALSE NEGATIVE (ALARM DID NOT SOUND WHEN > 20 ML OF CONTRAST HAD EXTRAVASATED). IT IS NOT POSSIBLE TO DETERMINE IF TECHNIQUE IS AN ISSUE OR IF THE DEVICE WAS ACTUALLY ARMED. A FALSE NEGATIVES AN EXPECTED EVENT AND EXTRAVASATIONS OF < 100 ML OF NONIONIC CONTRAST MEDIA HAVE ONLY A MODEST PROBABILITY OF CAUSING SERIOUS HARM OR PERMANENT INJURY TO THE PATIENT. NO MEDICAL OR SURGICAL INTERVENTION OTHER THAN A COLD COMPRESS WAS REQUIRED. PMA/510)K): K063029.

    Description of Event or Problem · 1

    EXTRAVASATION: A (B)(6) YEAR OLD FEMALE PRESENTED FOR AN ABDOMEN/PELVIS CT SCAN TO RULE OUT SERIOUS GI DISEASE SUCH AS COLORECTAL CA BASED ON SYMPTOMS OF PAIN AND RECTAL BLEEDING. PROTOCOL WAS TO INJECT 75 ML OF NONIONIC CONTRAST (VISIPAQUE 320) AT A FLOW RATE OF 3.0 ML/SEC THROUGH A 20G ANGIOCATH "Y" PORT. THE INJECTION WAS COMPLETED WITH ALL 75 ML ADMINISTERED BUT NO CONTRAST ENHANCEMENT WAS SEEN ON THE SCOUT VIEW. THE EDA (EXTRAVASATION DETECTION ACCESSORY) WAS REPORTEDLY ARMED BUT THE ALARM DID NOT SOUND AND IT WAS DETERMINED THAT ESSENTIALLY ALL OF THE 75 ML INJECTED HAD EXTRAVASATED. THE PATIENT HAD NOT SIGNALED THAT THERE WAS ANY PAIN OR BURNING SENSATION DURING THE INJECTION. THE CT SCAN WAS NOT PERFORMED. THE PATIENT'S ARM WAS ELEVATED AND COLD COMPRESSES WERE APPLIED. THE PATIENT WAS RELEASED FROM THE HOSPITAL IN GOOD CONDITION AND WITHOUT COMPLICATION FROM THE EXTRAVASATION. WORLDWIDE CASE ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361138 ACIST (CT) CONTRAST MEDIUM INJECTION SYSTEM DXT ACIST MEDICAL SYSTEMS, INC. CTA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR VISIPAQUE 320 (IODIXANOL) (NI)