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

Model Number	844007
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Codes	Extravasation (1842); Pain (1994); Injection Site Reaction (4562)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Overall investigation summary: a complaint was received on optivantage injector 844007 serial number (b)(6) alleging an extravasation due to the injector pressure not being accurate.Additional information was received stating that this is an isolated incident where approximately 2ml of an unspecified contrast agent was extravasated into the patient's tissue, causing swelling and pain.The patient was later discharged with no adverse reactions.Regional service engineer evaluated the injector, conducting verification tests on flow rate and pressure limits.It was determined that the injector was fully operational and was not the cause of the extravasation.The injector was then returned to customer use.Regional service suggests that the cause was the improper placement of the needle.Extravasations are generally caused by the operator.The injector does not have the capability to detect nor prevent an extravasation; however, precautions to minimize the likelihood of an extravasation are provided in the instructions for use.Additionally, the optivantage ifu describes patency check techniques.A review of guerbet's complaint tracking system shows no related complaint activity on this unit.Impact assessment summary: no serious or long term injury to the patient reported imdrf codes: b01; c23; d20, d11.Root / probable cause code: process/methods - inadequate/incorrect procedure.Root / probable cause summary: refer to investigation summary.No defect/malfunction of injector.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 released for use.
Event or Problem Description
This case was reported by a facility in (b)(6) china on 25 september 2024.Details of the case are as described below: setting name: (b)(6).Product name: high pressure injector (optivantage dh) injury: serious injury manifestations: drug extravasation, local subcutaneous edema at the indwelling needle location, and obvious pain.Instrument failure: high pressure injector pressure is not accurate use process: on (b)(6) 2024, the patient underwent cta in the arteries of both lower limbs.The radiology nurse first conducted two unblockage tests, each with a volume of 5ml normal saline and a speed of 4ml/s.The patient had no local swelling with the retention needle and no self-reported pain and discomfort.Normal scanning and injection of contrast agent began after the end of the experiment.When the scan was nearly half over, the machine issued a high pressure alarm, prompting the injection to continue or stop.At this time, the operator found that almost all the injection of contrast agent had been completed, and the scan was completed after the injection was stopped.After the patient returned to the ward, the doctor gave magnesium sulfate wet compress and ice treatment, and on (b)(6) 2024, the patient was discharged after the examination found that the edema had subsided and there were no adverse reactions.Cause analysis: unable to determine event cause analysis description: the drug extravasation, there may be the problem of inaccurate pressure of high pressure injector.Preliminary treatment: notified the operating enterprise, and contacted the factory engineer, agreed to come over for a detailed overhaul of the machine, and let the device pressure test.

• Brand Name: INJ. OPTIV DH, W/OEM
• Common Device Name: INJ. OPTIV DH, W/OEM
• Manufacturer (Section D): LIEBEL-FLARSHEIM; 2111 e. galbraith rd; cincinnati OH 45237
• Manufacturer Contact: jacob miller ; 2111 e. galbraith rd; cincinnati, OH 45237 ; 5139485765
• MDR Report Key: 20522788
• Report Number: 1518293-2024-00018
• Device Sequence Number: 13022713
• Product Code: IZQ
• UDI-Device Identifier: 10746190002727
• UDI-Public: 0110746190002727
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 10/24/2024

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: 844007
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2022
• 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