MAUDE Adverse Event Report: LIEBEL-FLARSHEIM INJ. OPTIV DH,SI W/OEM

Model Number	844005
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	Air Embolism (1697)
Type of Reportable Event	Malfunction
Event or Problem Description
This case was reported by a facility in brazil on 28 may 2026.The customer states that air was injected into the patient instead of contrast.
Additional Manufacturer Narrative
Overall investigation summary: a complaint was received on optivantage injector 844005 serial number (b)(6) alleging air was injected into a patient instead of contrast and the customer requested evaluation of the injector.Regional service was dispatched to the customer site to investigate the customer report.Service engineer reported that the injector was operational during the technical visit, with no errors or any issue detected.Operational tests were performed, calibration was verified, and instructions on correct usage were provided to those present.Instructions for the proper purging of air from the system prior to injection, as well as precautions, are covered in detail in the instructions for use (ref.Ifu, 848581 revision c, section 4.1), including steps to prevent air injections.Additionally, the optivantage injector sends a prompt to the operator requiring them to ensure all air is purged from the system and associated consumables, prior to injection.The operator must press a button on the injector acknowledging this has been completed prior to the device enabling the injection.Therefore, air injections are typically user related.The equipment did not display any errors during testing which may indicate an operational error during use.Service engineer recommended that refresher training be conducted with the unit's staff.The injector was released for customer use.A review of guerbet complaint tracking system (cts) showed no related complaint activity for this device.Impact assessment summary: no injury to the patient/user reported.Imdrf codes: b01; c23; d11.Root / probable cause code: improper use of device.Root / probable cause summary: refer to investigation summary.No additional capa required at this time.Guerbet quality will continue to monitor and trend for similar issues.These trends and issues are reported on during quality metrics review and during the management reviews to consider input for additional corrective action.

• Brand Name: INJ. OPTIV DH,SI W/OEM
• Common Device Name: INJ. OPTIV DH,SI W/OEM
• Manufacturer (Section D): LIEBEL-FLARSHEIM; 2111 e. galbraith rd; cincinnati
• Manufacturer Contact: jacob miller ; 2111 e. galbraith rd; cincinnati, OH
• MDR Report Key: 25561976
• Report Number: 1518293-2026-00023
• Device Sequence Number: 10012949
• Product Code: IZQ
• UDI-Device Identifier: 10746190002710
• UDI-Public: 0110746190002710
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K063503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 06/19/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 844005
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown