inforMED
OtherDXT

LIEBEL-FLARSHEIM MALLINCKRODT ANGIOMAT ILLUMENA CT INJECTOR

Received Jul 21, 2025

Report MW5173028 · MDR key 22556393

Device

Generic name

Injector And Syringe, Angiographic

Manufacturer

Mallinckrodt

Model number

LLLUMENA

Product problems

  • Misfire
  • Device-Device Incompatibility

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

AT 16:03 ON (B)(6) 2025, WHEN PERFORMING AN INTERVENTIONAL SURGERY ON A PATIENT IN THE DEPARTMENT OF NEUROSURGERY, THE HIGH-PRESSURE SYRINGE INJECTION DEVICE SUDDENLY MALFUNCTIONED. AFTER THE PRESET PRESSURE PARAMETERS, THE DEVICE DID NOT RESPOND WHEN THE SYRINGE WAS TRIGGERED, OR NON-COMMANDED INTERMITTENT INJECTION OCCURRED, RESULTING IN DISCONTINUOUS DELIVERY OF CONTRAST AGENT. CHECKED WHETHER THE PIPELINE WAS TWISTED, SWITCHED TO MANUAL INJECTION MODE, COMPLETED NECESSARY OPERATIONS, AND ENSURED THE PROGRESS OF THE SURGERY. DURING VERTEBRAL ARTERY ANGIOGRAPHY, THE HIGH-PRESSURE SYRINGE AND THE DSA MACHINE WERE NOT LINKED. AFTER REPEATED RESTARTS, THE FAULT WAS STILL NOT RESOLVED. THE INSTRUMENT REPAIR TEAM WAS CONTACTED FOR WARRANTY REPAIR. THE TECHNICIAN CONTINUED TO LOOK FOR THE CAUSE AND THE FAULT WAS RESOLVED HALF AN HOUR LATER.