LF 847002Recalls & reported problems
Liebel-Flarsheim Company LLC · OptiOne Single-Head CT Contrast Delivery System · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10746190002758), received between Apr 24, 2024 and Apr 24, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Infusion or Flow Problem” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Infusion or Flow Problem1
Patient problems
- Extravasation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 24, 2024Infusion or Flow Problem; Infusion or Flow Problem
THIS CASE WAS REPORTED BY A FACILITY IN BRASILIA, BRAZIL ON (B)(6) 2024. REPORTER INFORMED THAT "IT'S INFUSING IT WRONG, EXTRAVASATING CONTRAST."I REQUEST PREVENTIVE MAINTENANCE AND FUNCTIONAL VERIFICATION OF THE EQUIPMENT, IN ONE WEEK THERE WERE 4 OVERFLOWS. ADDITIONAL INFORMATION RECEIVED ON 29-MAR-2024: PATIENT WAS CONNECTED. PATIENT HAD EXTRAVASATION. WAITING FOR ADDITIONAL INFORMATION IN REGARDS TO PATIENT. ADDITIONAL INFORMATION RECEIVED ON 01-APR-2024: THERE WAS NO REPORT OF AN ERROR MESSAGE ON THE INJECTOR. -WHAT WAS THE FLOW RATE AND THE PRESSURE LIMIT THEY PROGRAMMED AND THE ACTUAL FLOW RATE THEY SAW DURING THE PROCEDURE? THE FLOW RATE NORMALLY USED HAS NOT BEEN GREATER THAN 3.5ML/S -WHAT WAS THE OUTCOME OF THE 4 PATIENTS? DID THE 4 OF THEM HAVE EXTRAVASATION OR ONLY THE LAST ONE ? THERE WERE 3 CASES REPORTED. NONEOF THE 3 EXAMS WERE COMPLETED. 2 I HAVE ALREADY DISCHARGED; 1 I WILL STILL FOLLOW UP UNTIL 29 MAR 2024. SO FAR, NONE HAVE HAD ANY INJURIES. FOLLOW-UPS WERE CARRIED OUT BY TELEPHONE; DISCHARGES WERE GIVEN AFTER PATIENTS REPORTED BEING ASYMPTOMATIC. -IS IT POSSIBLE TO HAVE THE NAME OF CONTRAST MEDIA USED IF IT IS A GUERBET PRODUCT ? HENETIX, BATCH: 23WC369B, WAS M
Patient problems: Extravasation
MAUDE report 19173637 ↗
Other Injector, Contrast Medium, Automatic devices
- MEDRAD® Stellant FLEX Syringe Kit FLEXD-150-SPKBayer Medical Care Inc. · Injector, Contrast Medium, Automatic1 recall0 reports
- MEDRAD® Stellant FLEX CT Injection System with Certegra® WorkstationBayer Medical Care Inc. · Injector, Contrast Medium, Automatic19 reports
- MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation (Upgrade)Bayer Medical Care Inc. · Injector, Contrast Medium, Automatic16 reports
- LF 844005Liebel-Flarsheim Company LLC · Injector, Contrast Medium, Automatic6 reports
- FastLoad™ MR Syringe Pack 017356Bracco Injeneering SA · Injector, Contrast Medium, Automatic4 reports
- EmpowerCTA®+ Injector System 017285Bracco Injeneering SA · Injector, Contrast Medium, Automatic2 deaths3 reports
- LF 844007Liebel-Flarsheim Company LLC · Injector, Contrast Medium, Automatic2 reports
- UL_INJECT XD 8000Ulrich GmbH & Co. KG · Injector, contrast medium, automatic1 death1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.