LIEBEL-FLARSHEIM MALLINCKRODT ANGIOMAT ILLUMENA CT INJECTOR
Received Jul 21, 2025
Report MW5173028 · MDR key 22556393
Device
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.