MalfunctionFIH
PERCUPUMP TOUCHSCREEN INJECTOR W/ EDA
Received Feb 18, 2005 · Event occurred Dec 1, 2004
Report 2411512-2005-00004 · MDR key 589808
Device
Generic name
Ct Injector W/ Extravasation Accessory
Manufacturer
E-z-em, Inc.Model number
NACatalog number
8805
Lot number
*
Product problems
- Unknown (for use when the device problem is not known)
Patient
67 YR
- Extravasation
- Infiltrates
- Therapy/non-surgical treatment, additional
Narrative
Description of Event or Problem
DURING AN INJECTION OF INTRAVENOUS CONTRAST AT A RATE OF 1.7 CC/SEC THE PATIENT'S IV INFILTRATED (RIGHT ANTECUBITAL SITE) AND APPROXIMATELY 90 CC'S OF OMNIPAQUE 300 EXTRAVASATED INTO THE SURROUNDING SOFT TISSUES OF THE UPPER RIGHT ARM. EXTRAVASATION SEEN ON THE CT SCAN.