MalfunctionFIH
PERCUPUMP TOUCHSCREEN INJECTOR W/EDA
Received Feb 17, 2005 · Event occurred Dec 1, 2004
Report 2411512-2005-00003 · MDR key 578547
Device
Generic name
Ct Injector W/extravasation Accessory
Manufacturer
E-z-em, Inc.Model number
NACatalog number
8805
Lot number
NA
Product problems
- Unknown (for use when the device problem is not known)
Patient
50 YR
- Extravasation
- Infiltration into Tissue
Narrative
Description of Event or Problem
DURING AN INJECTION OF INTAVENOUS CONTRAST, AT A RATE OF 1.4 CC/SEC, THE PT IV INFILTRATED. CONTRAST EXTRAVASATED INTO THE SOFT TISSUE OF THE DORSAL AREA OF THE LEFT HAND. APPROX 30 CC'S OF CONTRAST AGENT WAS EXTRAVASATED. NO INFORMATION WAS PROVIDED REGARDING HOW THE PT WAS TREATED.