BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACIST

    MDR report key: 1271816 · Received November 24, 2008

    Report

    Report Number
    2134243-2008-00011
    Event Type
    Malfunction
    Date Received
    November 24, 2008
    Date of Event
    October 15, 2008
    Report Date
    November 21, 2008
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    PMA / PMN Number
    K991103
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN DETERMINED THAT WHEN USING THE ACIST ANGIOGRAPHIC INJECTION SYSTEM MODEL CVI TO SYNCHRONIZE WITH THE TOSHIBA INFINIX-I CARDIOVASCULAR X-RAY SYSTEM, THERE IS A POTENTIAL FOR MULTIPLE INJECTIONS OF CONTRAST MEDIA WHEN ONE INJECTION WAS INTENDED. THIS WOULD RESULT IN THE PATIENT RECEIVING A LARGER THAN INTENDED VOLUME OF CONTRAST MEDIA. THOROUGH INVESTIGATION AND TESTING BY ACIST AND TOSHIBA TECHNICAL STAFF DETERMINED THAT THE POTENTIAL MULTIPLE INJECTIONS CAN OCCUR ONLY WHEN THE ACIST ANGIOGRAPHIC INJECTION SYSTEM MODEL CVI IS CONNECTED IN THE SYNCHRONIZATION MODE WITH TOSHIBA INFINIX- I X-RAY SYSTEM AND ONLY WHEN THE ACIST CVI INJECTION SYSTEM IS BEING USED FOR "LOW VOLUME INJECTIONS" DEFINED AS LESS THAN 20ML TOTAL VOLUME OF CONTRAST AND FLOW RATES OF LESS THAN 10ML/SECOND. THE POTENTIAL FOR THE DESCRIBED MULTIPLE INJECTIONS SCENARIO TO THE BEST OF OUR KNOWLEDGE WILL NOT OCCUR WITH OTHER BRANDS OF X-RAY SYSTEM (GE, PHILLIPS, SIEMENS, AND OTHER TOSHIBA MODELS). THE MEDICAL ADVISORY BOARD OF ACIST MEDICAL SYSTEMS, INC. DISCUSSED THE POTENTIAL CLINICAL CONSEQUENCES IF A PATIENT RECEIVED ADDITIONAL DOSES OF CONTRAST MEDIA. IN A PREDISPOSED PATIENT, THIS MIGHT RESULT IN TRANSIENT RENAL DYSFUNCTION WITH A REMOTE POSSIBILITY OF TRANSIENT NEED FOR DIALYSIS OR THE NEED FOR DIURETICS TO REDUCE INTRAVASCULAR VOLUME. THE MEDICAL ADVISORY BOARD ESTIMATES THAT ONE IN 20 PATIENTS WOULD BE PREDISPOSED. BASED ON THIS NUMBER AND THE LIKELIHOOD OF OCCURRENCE (APPROXIMATELY LESS THAN TWO IN 24,480 CASES), ACIST ESTIMATES THE RISK OF CONTRAST-INDUCED NEPHROPATHY WOULD BE ONE IN 244,800 PROCEDURES. INITIAL CORRECTIVE ACTIONS/PREVENTIVE ACTIONS IMPLEMENTED BY ACIST. AFFECTED USERS ARE BEING INSTRUCTED TO DISCONTINUE USE OF SYNCHRONIZED MODE BETWEEN THE CVI AND THE TOSHIBA INFINIX-I. THE CVI AND THE TOSHIBA INFINIX-I CAN STILL BE USED TOGETHER IN A NON-SYNCHRONIZED MODE (THE MAJORITY OF ACIST SYSTEMS IN USE ARE NOT SYNCHRONIZED WITH THE X-RAY SYSTEM). SINCE THE POTENTIAL FOR UNINTENDED MULTIPLE INJECTIONS EXIST ONLY IN THE SYNCHRONIZED MODE, THIS ACTION WILL PREVENT THE OCCURRENCE OF UNINTENDED MULTIPLE INJECTIONS. ACIST MEDICAL SYSTEMS IS WORKING WITH TOSHIBA TO RESOLVE THIS ISSUE. A RESOLUTION IS EXPECTED IN THE FIRST QUARTER OF 2009.

    Description of Event or Problem · 1

    USER FACILITY REPORTED: DURING AN ANGIOGRAPHIC PROCEDURE WHILE USING THE ACIST ANGIOGRAPHIC INJECTION SYSTEM MODEL CVI WITH X-RAY INTERFACE TO TOSHIBA INFINIX-I X-RAY FLUOROSCOPIC SYSTEM, MULTIPLE CONTRAST INJECTIONS OCCURRED WHEN ONE INJECTION WAS INTENDED. THE AMOUNT OF CONTRAST INJECTED WAS NOT REPORTED BY THE USER FACILITY. NO MEDICAL INTERVENTION WAS NECESSARY AND NO ADVERSE HEALTH EFFECTS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1