BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACIST

    MDR report key: 1931923 · Received December 11, 2010

    Report

    Report Number
    2134243-2010-00018
    Event Type
    Malfunction
    Date Received
    December 11, 2010
    Date of Event
    November 12, 2010
    Report Date
    December 10, 2010
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    PMA / PMN Number
    K991103
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2010, THE ACIST ANGIOGRAPHIC CONTRAST INJECTION SYS, MODEL CVI, WAS RETURNED TO ACIST FOR EVAL. UPON RECEIPT OF THE INJECTION SYS, IT WAS OBSERVED THAT THERE WERE DEPOSITS OF DRIED CONTRAST MEDIA ON THE SYSTEM'S MOUNTING CHAMBER, AIR COLUMN DETECT (ACD) SENSOR, MANIFOLD VALVE SENSOR, CONTRAST SENSOR, AND SYRINGE VALVE SENSOR. ACIST PERFORMED FUNCTIONAL TESTING OF THE INJECTION SYS IN THE CONDITION IN WHICH IT WAS RECEIVED AND AN INTERMITTENT FAILURE OF THE ACD SENSOR WAS NOTED. THE INJECTION SYS AND ACD SENSOR WERE CLEANED AND AN INTERMITTENT FAILURE OF THE ACD SENSOR WAS AGAIN NOTED UPON THE ADDITIONAL TESTING. THE ACD SENSOR WAS REPLACED AND THE ACD SENSOR OPERATED TO SPECIFICATIONS. THE DIAGNOSTIC LOG DOWNLOAD FROM THE ACIST INJECTION SYS WAS REVIEWED BY ACIST ENGINEERING. THE LOG INDICATED THAT THE INJECTION SYS HAD DETECTED AN AIR BUBBLE AND TERMINATED THE SALINE FLUSH AND THAT THE HOSPITAL STAFF INITIATED A "STANDBY" COMMAND TO STOP THE SALINE FLUSH, IN ADDITION TO THE TERMINATION OF THE FLUSH BY THE INJECTION SYS. PER ACIST USER'S MANUAL, THE ACD 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 CLEANING AIR FROM THE ENTIRE PT KIT AND ANGIOGRAPHIC CATHETER. THE DISPOSABLE KITS USED DURING THE EVENT AND COPY OF THE CINE-ANGIOGRAM WERE NOT RETURNED TO ACIST, THEREFORE, NO ANALYSIS WAS MADE OF THESE ITEMS. THE SOURCE OF THE AIR CANNOT BE CONFIRMED, ALTHOUGH THE AIR MAY HAVE ORIGINATED FROM THE SALINE BAG, AS THE HOSPITAL STAFF NOTED IT HAD EMPTIED AFTER THE AIR HAD BEEN OBSERVED IN THE HIGH-PRESSURE TUBING AND THE CATHETER HAD BEEN REMOVED FROM THE PT. AN INTERMITTENT FAILURE OF THE ACD SENSOR WAS CONFIRMED BY ACIST DURING TESTING. BASED ON REVIEW OF THE INJECTION SYSTEM'S DIAGNOSTIC LOG, THE ACD SENSOR WAS FUNCTIONAL AT THE TIME OF THE EVENT, AND THE INJECTION SYS TERMINATED THE SALINE FLUSH DUE TO DETECTION OF AIR. PER THE HOSPITAL'S PHYSICIAN, THERE WAS NO EVIDENCE THAT THE AIR REACHED THE PT: THERE WAS NO AIR VISIBLE ON THE CINE-ANGIOGRAM AND THE PT'S REPORTED SYMPTOMS WERE PRE-EXISTING. THIS REPORT IS CLOSED.

    Description of Event or Problem · 1

    NARRATIVE: USER FACILITY REPORTED: AT THE CONCLUSION OF AN LV ANGIOGRAM, THE CATHETER WAS FLUSHED WITH SALINE FOR POST-PRESSURE MEASUREMENT. THE PHYSICIAN AND STAFF HAD NOT NOTICED THAT THE SALINE BAG HAD EMPTIED. AIR WAS OBSERVED IN THE HIGH-PRESSURE TUBING AT THE CONNECTION TO THE CATHETER. THE PHYSICIAN IMMEDIATELY REMOVED THE CATHETER FROM THE PT BEFORE THE AIR REACHED THE PT. THERE WAS NO EVIDENCE THAT AIR ENTERED THE PT. THE PT HAD SEVERE BRADYCARDIA AND HYPOTENSION; THE PHYSICIAN REPORTED THAT THESE ARE UNRELATED TO THE EVENT (PT HISTORY INCLUDES BRADYCARDIA AND THE PT WAS GETTING A PACEMAKER). THERE WERE NO OTHER PT SYMPTOMS REPORTED. (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 58 YR