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	Serious Injury
Event or Problem Description
This case was reported by a facility in paris, france on (b)(6) 2025.Customer reported that they were informed by other individuals that during the private friday morning session at the (b)(6), a patient had to be evacuated due to bubbles in the optivantage injector.The patient underwent a contrast-enhanced ct scan of the ent area.The scan revealed air bubbles in the pulmonary arteries, as observed by the doctor.The patient was transferred to (b)(6) hospital and hospitalized for two days.He received hyperbaric chamber treatment and fully recovered without any lasting effects from the incident.The purge was performed and confirmed by the radiology technician to the doctor at the time of the incident.
Additional Manufacturer Narrative
Overall investigation summary a complaint was received on optivantage injector 844005 serial number (b)(6) alleging air bubbles in the injector resulting in a patient evacuation.A scan was conducted and found air bubbles in the pulmonary arteries.The patient was hospitalized for two days and received hyperbaric chamber treatment before fully recovering without lasting effects.Air injections are generally not related to the injector but are generally user related causes.The optivantage is not equipped with air detectors; however, the ifu includes instructions for the proper purging of air from the system prior to injection, as well as precautions, and steps to prevent air injections.Additionally, the optivantage sends a prompt to the operator requiring the operator to ensure all air is purged from the system and associated consumables prior to the injection.The operator must press the screen acknowledging this has been completed prior to the device enabling the injection.For these reasons, air injections are generally user related.A service engineer went on site to check the injector.Service cleaned contrast from the unit, checked side a and b pressure and side a and b volume with no issue noted.The injector was tested for proper operation and found to be fully functional.Unit remained in customer use.A review of guerbet complaint tracking system (cts) showed no related complaint activity for this device.Impact assessment summary: patient was hospitalized for two (2) days but recovered with no additional adverse effects.Imdrf codes: b13; c23; d1101.Root / probable cause code.Personnel - performance - failed to follow procedure.Root / probable cause summary: see investigation summary for details.Air injections are generally user related.There is no need for a capa at this time.These issues are reported upon during periodic quality reviews to consider input for corrective action.Qa will continue to monitor and trend for similar issues.Disposition summary: unit remained in use.

• 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: 23351267
• Report Number: 1518293-2025-00016
• Device Sequence Number: 12991524
• Product Code: IZQ
• UDI-Device Identifier: 10746190002710
• UDI-Public: 0110746190002710
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 10/21/2025

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: 09/24/2025
• Initial Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2020
• 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