MalfunctionFIH
PERCUPUMP TOUCHSCREEN INJECTOR W/EDA
Received Apr 13, 2006 · Event occurred Mar 14, 2006
Report 2411512-2006-00001 · MDR key 701044
Device
Product problems
- False Negative Result
Patient
74 YR
Narrative
Description of Event or Problem
CUSTOMER REPORTED THAT AN EXTRAVASATION OCCURRED WHILE INJECTION IV CONTRAST INTO A PT DURING A ABDOMINAL/PELVIC CT EXAM. THE EDA PATCH WAS IN USE HOWEVER THE SYSTEM DID NOT ALARM TO STOP THE INJECTION. TOTAL AMOUNT OF INJECTION WAS 100ML NON-IONIC CONTRAST AT A FLOW RATE OF 2.5ML/SEC INTO THE PT'S WRIST. FACILITY ESTIMATES THE ENTIRE INJECTION AMOUNT (100ML) EXTRAVASATED. PT DID EXPERIENCE SOME SWELLING AT THE INJECTION SITE, HOWEVER NO TREATMENT WAS INDICATED.
Remedial action
- Patient Monitoring