BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACIST

    MDR report key: 485139 · Received September 18, 2003

    Report

    Report Number
    2134243-2003-00005
    Event Type
    Malfunction
    Date Received
    September 18, 2003
    Date of Event
    October 16, 2002
    Report Date
    September 18, 2003
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PER THE REPORT SUBMITTED TO ACIST MEDICAL SYSTEMS, INC., AIR WAS NOT INJECTED INTO THIS PATIENT AND NO ADVERSE EVENT IS ASSOCIATED WITH THIS COMPLAINT REPORT. DURING AN INTERVENTIONAL PROCEDURE, THE PHYSICIAN NOTICED AIR AROUND THE MANIFOLD SPRING (ENTRY FROM CAP). HE REPLACED THE [BT2000] KIT AND AGAIN NOTICED AIR IN THE SAME LOCATION ON THE SECOND BT 2000 KIT. THE AIR REPORTEDLY MOVED UP THE 2.5" LINE AND HIGH PRESSURE TUBING TOWARD THE AIR COLUMN DETECT SENSOR DURING SMALL "PUFF" INJECTIONS. THE PHYSICIAN DETERMINED TO CONTINUE USING THE SYSTEM FOR ANOTHER 5+ HOURS. NOTWITHSTANDING THE OBSERVATION OF AIR ENTERING THE PATIENT MANIFOLD ASSEMBLY AND ITS DETECTION BY THE AIR COLUMN DETECT SENSOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACIST ANGIOGRAPHIC INJECTION SYSTEM DXT ACIST MEDICAL SYSTEMS, INC. CMS2000 BT2000: 182705

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other