MAUDE Adverse Event Report: LIEBEL-FLARSHEIM INJECTOR OPTIONE BASE SYSTEM

Model Number	847002
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Extravasation (1842)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Overall investigation summary: a complaint was received on optione injector 847002 serial number (b)(6) alleging that they had experienced extravasations on multiple patients and wanted service to evaluate the injector.The photos provided by the customer confirmed that these patients had experienced an extravasation.A service engineer was dispatched to the customer site and conducted performance testing.The testing verified that the flow rate & pressure limits were within permitted range and that the equipment was fully operational.The issue reported by the customer was determined to not be caused by the equipment.The injector system was fully operational and released back to customer for use.Extravasations are generally due to user related issues.The 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.The service engineer did note that the customer uses syringes not approved for use with this injector, which could have been a factor in these cases.Service therefore advised the customer to have a guerbet application team conduct training to help mitigate the recurrence of the incident.The customer accepted and the training was completed.A review of guerbet complaint tracking system (cts) showed no related complaint activity for this device.Impact assessment summary: extravasation (injury) to the four (4) patients imdrf codes: b01; c23; d11 root / probable cause code: personnel - training - inadequate root / probable cause summary: refer to investigation summary.No additional capa required at this time.Guerbet quality will continue to monitor and trend forsimilar 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 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 made 1.2ml per kg.

• Brand Name: INJECTOR OPTIONE BASE SYSTEM
• Common Device Name: INJECTOR OPTIONE BASE SYSTEM
• Manufacturer (Section D): LIEBEL-FLARSHEIM; 2111 e. galbraith rd; cincinnati OH 45237
• Manufacturer Contact: fred reckelhoff ; 2111 e. galbraith rd; cincinnati 45237
• MDR Report Key: 19173637
• Report Number: 1518293-2024-00010
• Device Sequence Number: 12717182
• Product Code: IZQ
• UDI-Device Identifier: 10746190002758
• UDI-Public: 0110746190002758
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K152361
• 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,Other
• Type of Report: Initial
• Report Date (Section B): 04/24/2024

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: 847002
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2024
• Initial Report FDA Received Date: 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2018
• 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