inforMED
MalfunctionDQF

SPECTRIS MRI INJECTION SYSTEM

Received Feb 20, 2004 · Event occurred Nov 1, 2003

Report 512240 · MDR key 512240

Device

Generic name

Mri Injector

Manufacturer

Medrad, Inc.

Model number

SDV200

Catalog number

*

Lot number

*

Product problems

  • Sticking
  • Malfunction

Patient

70 YR

  • Unknown (for use when the patient's condition is not known)

Narrative

Description of Event or Problem

AN IV LINE WAS CONNECTED TO THE PT AND THE INJECTOR WAS PRIMED TO START KVO [KEEP VEIN OPEN]. TO KEEP IV LINE OPEN, START WAS MASHED [PUSHED] ON THE INJECTOR. THE BUTTON MAY HAVE BEEN STUCK BECAUSE CONTRAST WAS INJECTED INSTEAD OF KVO. DOCTORS HAD TO RESCHEDULE STUDY UNTIL THE NEXT DAY. BEFORE USING THE INJECTOR AGAIN, BOTH SYRINGES WERE LOADED WITH WATER AND RAN THROUGH SET UP AND INJECTION AGAIN. SYSTEM OK'D. DEVICE USAGE PROBLEM: DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO.