INJECTOR AND SYRINGE, ANGIOGRAPHIC
Received Jan 8, 2024 · Event occurred Oct 25, 2023
Report MW5149965 · MDR key 18475947
Device
Generic name
Injector And Syringe, Angiographic
Manufacturer
Liebel-flarsheim Company LlcPatient
60 YR · Male
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
USE PROCESS DESCRIPTION: ON (B)(6) 2023, THE PATIENT UNDERWENT SELECTIVE ARTERIOGRAPHY + HEPATIC ARTERY EMBOLIZATION. BEFORE THE SURGERY, THE HIGH-PRESSURE SYRINGE PUMP WAS CHECKED FOR GOOD PERFORMANCE AND COULD BE USED. DURING THE SURGERY, THE TOUCH SCREEN OF THE HIGH-PRESSURE SYRINGE PUMP SUDDENLY FAILED, AND THE DRUG DOSE COULD NOT BE CHANGED AND IT COULD NOT BE USED. CALMED THE PATIENT'S EMOTIONS AND CONTACTED THE DEVICE DEPARTMENT FOR REPAIR. AFTER REPAIRED, IT WAS STILL UNUSABLE AND THERE WAS NO SPARE DEVICE, SO THE SURGERY WAS TERMINATED. REPORTED TO THE DEVICE DEPARTMENT FOR REPAIR AND TERMINATED THE SURGERY. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).