UL_INJECT
Received May 2, 2025 · Event occurred Apr 4, 2025
Report 9612420-2025-00102 · MDR key 21948403
Device
Generic name
Ulrichinject Ct Motion Pedestal Version With Heater And Bluetooth
Manufacturer
Ulrich Gmbh & Co. KgModel number
XD 8000-001Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Cardiac Arrest
- Cardiac Arrest
Narrative
Description of Event or Problem
ACCORDING TO USER INFORMATION: "ON (B)(6) 2025 AT 11:45 A.M., MS. (B)(6) REPORTED THE DEATH OF A PATIENT DUE TO AIR IN THE HEART IN RELATION TO (B)(6). A CT THORAX ABDOMEN EXAMINATION WITH ULTRAVIST 300 IN 500 ML GLASS BOTTLES AT A FLOW RATE OF 3ML/S WITH 21ML NACL / 100ML KM / 30ML NACL. THE CONTRAST AGENT WAS NOT PREHEATED. A 320 CM PATIENT TUBE WAS USED. ACCESS WAS VIA A PORT SYSTEM THAT IS ALSO USED FOR CHEMOTHERAPY. MS. (B)(6) WAS UNABLE TO STATE THE AMOUNT OF AIR. THE INJECTOR DID NOT SHOW ANY ERROR MESSAGES."
Remedial action
- Inspection