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

Model Number	844005
Medical Device Problem Code	Inaccurate Delivery (2339)
Health Effect - Clinical Code	Extravasation (1842)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Overall investigation summary a complaint was received on optivantage injector 844005 serial number (b)(6) alleging eight (8) separate extravasations and requested an evaluation of the equipment.The service engineer completed an inspection of the injector, conducted performance tests according to protocol, and verified flow rate & pressure limits were all within permitted range.Service stated the reported problem was attributable to bad connection to patient.No pressure problems found.Equipment is operational.The technician who handled the case informed the guerbet pharmacovigilance analyst that the equipment did not present any errors and it seemed that the extravasation was due to operational error.The technician also stated that an extravasation also occurred more than once i.N another injector that is not a guerbet product, supporting this likely root cause of operator based.The optivantage injector does not have the capability to prevent or detect an extravasation (infiltration).However, precautions to minimize an extravasation are provided in the operator's manual.Additionally, described in the manual are i.V.Site patency check techniques, including a manual method and another using a patency key in the setup screen.A review of guerbet complaint tracking system (cts) showed no related complaint activity for this device.Impact assessment summary no long term injury to the patient reported imdrf codes: b01; c23; d11 root/probable cause code process/methods - inadequate/incorrect procedure 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.Disposition summary unit remained in service.
Event or Problem Description
This incident was reported by a facility (b)(6), brazil on date february24, 2025.Reporter informed that "contrast extravasation.Eight incidents of contrast extravasation were reported in february.The assembly of the circuit and the entire process up to the patient have already been checked, and in view of this, we request an urgent check of the equipment.".

• Brand Name: INJ. OPTIV DH,SI W/OEM
• Common Device Name: INJ. OPTIV DH,SI W/OEM
• Manufacturer (Section D): LIEBEL- FLARSHEIM; 2111e. galbraith rd; cincinnati OH 45237
• Manufacturer Contact: jacob miller ; 2111 e. gralbraith rd; cincinnati, OH 45237 ; 5139485765
• MDR Report Key: 21654029
• Report Number: 1518293-2025-00005
• Device Sequence Number: 15803046
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 03/20/2025

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?: No
• 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: 02/24/2025
• Initial Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown