inforMED
MalfunctionFIH

PERCUPUMP TOUCHSCREEN INJECTOR W/EDA

Received Apr 13, 2006 · Event occurred Mar 14, 2006

Report 2411512-2006-00001 · MDR key 701044

Device

Generic name

Ct Injector System

Manufacturer

E-z-em, Inc.

Model number

NA

Catalog number

8805

Lot number

NA

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