BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACIST

    MDR report key: 5124299 · Received October 2, 2015

    Report

    Report Number
    2134243-2015-00012
    Event Type
    Injury
    Date Received
    October 2, 2015
    Date of Event
    August 31, 2015
    Report Date
    September 30, 2015
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    PMA / PMN Number
    K991103
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACIST ANGIOGRAPHIC CONTRAST INJECTION SYSTEM, MODEL CVI, SERIAL NUMBERS (B)(4) WERE RETURNED TO ACIST ON NOVEMBER 13, 2015 FOR TESTING. THE INJECTION SYSTEM WAS FUNCTIONALLY TESTED AND MET THE PRE-ESTABLISHED SPECIFICATIONS. THERE IS NO EVIDENCE OF DEVICE MALFUNCTION RELATED TO THIS EVENT BASED ON THE DATA FROM THE ANALYSIS OF THE INJECTOR. THE CONSUMABLE KITS USED DURING THE EVENT WERE DISCARDED BY THE HOSPITAL; 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 PATIENT 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 THE TESTING, THERE IS NO EVIDENCE OF DEVICE MALFUNCTION RELATED TO THIS EVENT. THE CAUSE OF THE EVENT IS INCONCLUSIVE. THIS REPORT IS CLOSED.

    Additional Manufacturer Narrative · 1

    THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI, HAS BEEN REQUESTED TO BE SENT TO ACIST FOR INVESTIGATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED TO FDA.

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE CUSTOMER PROVIDED ACIST MEDICAL SYSTEMS WITH UPDATED INFORMATION THAT THE PATIENT HAD FULLY RECOVERED AND WAS DISCHARGED FROM THE HOSPITAL.

    Description of Event or Problem · 1

    USER FACILITY REPORTED A PATIENT UNDERGOING A LEFT HEART CATHETERIZATION FOR HISTORY OF CHEST PAIN AND UNSTABLE ANGINA EXPERIENCED AN AIR INJECTION. UPON THE INITIAL CONTRAST INJECTION, APPROXIMATELY 8ML OF AIR WAS INJECTED INTO THE PATIENT'S LEFT CORONARY ARTERY (LCA). UPON INJECTION FOR FIRST VIEW, A SMALL AMOUNT OF CONTRAST WAS SEEN, THEN FOLLOWED BY VISIBLE AIR. FOLLOWING THE AIR INJECTION, THE PATIENT WENT INTO A VENTRICULAR FIBRILLATION, DISPLAYED HYPOTENSION WITH A SYSTOLIC BLOOD PRESSURE LESS THAN 90, ESCALATING TO A CODE EVENT. THE PATIENT WAS INTUBATED AND PLACED ON A BALLOON PUMP, AND TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) WHERE THE PATIENT REMAINED NON-RESPONSIVE FOLLOWING THE CODE EVENT. FOLLOWING THE AIR INJECTION, AND PRIOR TO THE CODE EVENT, THE PATIENT DID NOT REPORT ANY CHEST PAIN, THERE WAS NO ST SEGMENT CHANGE ON THE ECG, NO CARDIAC BIOMARKER ELEVATIONS, AND NO OTHER EVIDENCE OF A MYOCARDIAL INFARCTION EVENT. THE INITIAL REPORTER NOTED THAT THE INJECTION SYSTEM HAD RECENTLY DISPLAYED THE AIR COLUMN DETECTED MESSAGE, SYRINGE VALVE OPEN MESSAGE, AND MANIFOLD VALVE OPEN MESSAGES . THE ACIST CONSUMABLE KIT TUBING WAS RE-FLUSHED BEFORE THE INJECTION. THE USER FACILITY WAS UNABLE TO PROVIDE CINE-ANGIOGRAMS FOR FURTHER EVALUATION. AS OF 9/14/2015, THE PATIENT HAD NOT YET RECOVERED. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING PATIENT STATUS, BUT FURTHER INFORMATION HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SENT UPON RECEIVING ANY FURTHER INFORMATION REGARDING PATIENT STATUS OR EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654001 ACIST INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT ACIST MEDICAL SYSTEMS, INC. CVI

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| L| R