BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUPUMP CT INJECTOR W/EDA

    MDR report key: 274316 · Received April 14, 2000

    Report

    Report Number
    2432460-2000-00013
    Event Type
    Malfunction
    Date Received
    April 14, 2000
    Date of Event
    March 14, 2000
    Report Date
    March 14, 2000
    Manufacturer
    E-Z-EM, INC.
    Product Code
    FIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INJECTION FLOW RATE SET FOR 3.0 CC/SEC AND THE INJECTION SITE WAS THE ANTECUBITAL FOSSA. AFTER INJECTING THE ENTIRE 150 ML OF CONTRAST, AN EXTRAVASATION WAS NOTICED WHICH THE EDA PATCH DID NOT DETECT. THE PT WAS REFERRED TO A PLASTIC SURGEON FOR CONSULTATION AND WAS ADMITTED TO THE HOSPITAL OVERNIGHT. PT WAS RELEASED THE FOLLOWING MORNING WITHOUT FURTHER MEDICAL INTERVENTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| O DICKENSON.| 20 GAUGE ANGIOCATH MANUFACTURED BY BECTON| OMNIPAQUE 300 CONTRAST MFG BY NYCOMED.