BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACIST

    MDR report key: 2979985 · Received February 22, 2013

    Report

    Report Number
    2134243-2013-00001
    Event Type
    Other
    Date Received
    February 22, 2013
    Date of Event
    January 25, 2013
    Report Date
    February 22, 2013
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    PMA / PMN Number
    K991103
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACIST CONTRAST INJECTION SYSTEM, MODEL CVI, WAS TESTED ON (B)(6) 2013. THE INJECTION SYSTEM WAS FUNCTIONALLY TESTED AND THERE WAS NO EVIDENCE OF DEVICE MALFUNCTION. THE CONSUMABLE KITS USED DURING THE EVENT WERE DISCARDED BY THE HOSP, THEREFORE, NO ANALYSIS COULD BE MADE OF THESE ITEMS. THE ACIST CONTRAST INJECTION SYSTEM IS EQUIPPED WITH AN AIR COLUMN DETECT SENSOR. THE AIR COLUMN DETECT SENSOR SENSES AIR IN THE PROXIMAL END OF THE HIGH-PRESSURE (INJECTION) TUBING. IF AIR IS DETECTED IN THE TUBING, ALL FLUID DELIVERY FUNCTIONS ARE DISABLED. PER THE ACIST CVI USERS MANUAL, THE AIR COLUMN DETECT SENSOR IS DESIGNED TO AID THE USER IN THE DETECTION OF AIR COLUMNS IN THE INJECTION LINE, BUT IT IS NOT DESIGNED TO REPLACE THE VIGILANCE AND CARE REQUIRED OF THE OPERATOR IN VISUALLY INSPECTING FOR AIR AND CLEARING AIR FROM THE ENTIRE PT KIT AND ANGIOGRAPHIC CATHETER. THE AIR COLUMN DETECT MECHANISM IS TO BE USED IN CONJUNCTION WITH AND TO COMPLEMENT THE USER'S OTHER PROCEDURES FOR PREVENTING AIR INJECTIONS. ACIST'S RISK MANAGEMENT HAS APPROPRIATE RISK MITIGATIONS IN PLACE FOR POTENTIAL AIR EMBOLISM DUE TO USER ERROR, INCLUDING LABELING DESCRIBING AIR BUBBLE PRECAUTIONS AND THE USER MANUAL WHICH GUIDES THE USER THROUGH SET-UP AND PURGE OF THE INJECTOR SYSTEM. BASED ON TESTING OF THE INJECTOR, THERE IS NO EVIDENCE OF DEVICE MALFUNCTION. A F/U REPORT WILL BE SUBMITTED UPON COMPLETION OF REVIEW OF THE CINE-ANGIOGRAM BY ACIST'S MEDICAL ADVISORY BOARD.

    Description of Event or Problem · 1

    DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) FOR TREATMENT OF ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI), AIR WAS INJECTED INTO THE PT. THE PT'S CONDITION IMMEDIATELY DURING AND AFTER THE PROCEDURE WAS CRITICAL; THE PT REPORTEDLY RECOVERED THE SAME DAY. THE USER FACILITY DID NOT CONSIDER THE AIR INJECTION EVENT TO BE LIFE-THREATENING AND THE EVENT DID NOT RESULT IN PROLONGATION OF HOSPITALIZATION. WORLDWIDE CASE ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79249 ACIST ANGIOGRAPHIC INJECTION SYSTEM DXT ACIST MEDICAL SYSTEMS, INC. CMS2000 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other