MalfunctionIZQ
INJ, OPTIV, MULI
Received Jun 19, 2026
Report 1518293-2026-00024 · MDR key 25561975
Device
Product problems
- Unintended Movement
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THIS CASE WAS REPORTED BY A FACILITY IN CRUZ DE ALMAS, BRAZIL ON (B)(6) 2026. THE CUSTOMER STATES THAT DURING THE INTRAVENOUS VIA TEST WITH SALINE, THE INJECTOR PUMP DELIVERED 100 ML OF IODINATED CONTRAST AUTONOMOUSLY, WITHOUT ANY COMMAND FROM THE TECHNICAL TEAM. THE PATIENT ((B)(6), 70 YEARS OLD) WAS CLINICALLY EVALUATED, WITH NO IMMEDIATE COMPLICATIONS, HOWEVER, THE EXAM WAS RENDERED UNFEASIBLE DUE TO THE ABSENCE OF THE PRE-CONTRAST PHASE.THE EVENT OCCURRED DURING A PROCEDURE WITH THE PATIENT CONNECTED. THE PROCEDURE WAS NOT COMPLETED AND THERE WERE NO REPORTS OF PATIENT OR STAFF INJURIES.