BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUPUMP TOUCHSCREEN INJECTOR SYSTEM W/EDA

    MDR report key: 188180 · Received September 18, 1998

    Report

    Report Number
    2432460-1998-00012
    Event Type
    Malfunction
    Date Received
    September 18, 1998
    Date of Event
    August 15, 1998
    Report Date
    August 19, 1998
    Manufacturer
    E-Z-EM, INC.
    Product Code
    DXT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE "ANGIOCATCH" WAS PLACED IN THE PT'S FOREARM. THE PROTOCOLS WERE SET AND USED .8CC/SEC. THE TOTAL VOLUME OF THE SYRINGE WAS 89 CC'S. THE DR STATED THAT HE PLACED THE PATCH IN THE RIGHT PROXIMITY TO THE ANGIOCATH AND THERE WAS NOT ANY TAPE OVER OR UNDER THE PATCH. THE DR STARTED THE INJECTION AND PALPATED THE PATCH FOR THE FIRST 20 SEC. THE DR THEN LEFT THE ROOM. THE CONTROLLER ON THE INJECTOR READ "RANGE OK". THE PT DID NOT COMPLAIN UNTIL AFTER THE INJECTION WAS OVER. THE DR STATED THAT THE EXTRAVASATION WAS UNDER THE PATCH AND THE PT HAD A SWOLLEN FOREARM. PT HAD FULL RANGE AND MOTION OF WRIST AND FINGERS. PULSE WAS GOOD. COLD COMPRESSES WERE APPLIED AND THE PT OBSERVED INTERMITTENTLY. HAND SURGEON CALLED FOR CONSULT. THE PRINTOUT STATED THAT THE EXTRAVASATION DETECTION ACCESSORY WAS ENABLED FOR THE WHOLE INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCUPUMP TOUCHSCREEN INJECTOR SYSTEM W/EDA CT INJECTOR W/EXTRAVASATION ACCESSORY DXT E-Z-EM, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other 22 GAUGE NEEDLE.| OMNIPAQUE 300 (NON-IONIC) CONTRAST.