MAUDE Adverse Event Report: INTERA ONCOLOGY, INC INTERA 3000; HEPATIC ARTERY INFUSION PUMP

Model Number	AP-03000H
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Reaction to Medicinal Component of Device (4574)
Date of Event	06/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A device history review was performed and confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations that could have contributed to the reported event.Investigation determined that the reported elevated liver function tests (lfts) were not related to a malfunction or failure of the hepatic artery infusion pump.The information provided by the physician indicated that the event was associated with floxuridine (fudr) therapy.No device performance issues were identified, and there was no evidence that the pump contributed to the reported event.As the event was attributed to the drug therapy rather than the device, the information was reported to hikma pharmaceuticals on june 10, 2026, for their assessment and handling as appropriate.
Event or Problem Description
Intera oncology was notified that an medical science liaison (msl) received an email from the physician requesting guidance regarding dose reduction protocols for liver function test (lft) elevations associated with floxuridine (fudr) therapy.The msl recommended a telephone discussion, which occurred on (b)(6) 2026.During the call, the physician reported that the hepatic artery infusion pump had been placed during liver resection; however, the patient had residual gross disease in the liver and was therefore being managed as an unresectable placement.The physician stated that following cycle 3 of fudr, the patient experienced elevated lfts prior to a planned vacation.As a result, floxuridine treatment was held and the pump was filled with heparin/saline solution without dexamethasone.The physician reported that the lft elevations resolved during the treatment hold.Due to the patient's vacation schedule, an additional cycle of heparin/saline without dexamethasone was administered.Upon the patient's return on (b)(6) 2026, lft elevations were again observed.The physician reported that the pump was refilled with heparin/saline without dexamethasone and contacted intera oncology for guidance.During the discussion, recommendations from the memorial sloan kettering (msk) protocol regarding dose reduction following treatment hold and the inclusion of dexamethasone were reviewed.Questions regarding modified dosing were addressed and requested resources were provided.The physician stated that specific lft values were not available during the call because access to the medical record was not available at that time.On (b)(6) 2026, the physician provided the following laboratory results: (b)(6) 2026: ast 173 u/l, alt 268 u/l, alkaline phosphatase 181 u/l, total bilirubin 0.4 mg/dl.(b)(6) 2026: ast 32 u/l, alt 39 u/l, alkaline phosphatase 153 u/l, total bilirubin 0.3 mg/dl.

• Brand Name: INTERA 3000
• Common Device Name: HEPATIC ARTERY INFUSION PUMP
• Manufacturer (Section D): INTERA ONCOLOGY, INC; 180 wells avenue; suite 300a; newton MA 02459
• Manufacturer (Section G): INTERA ONCOLOGY, INC; 180 wells avenue; suite 300a; newton MA 02459
• Manufacturer Contact: jesus matos ; 180 wells avenue; suite 300a; newton, MA 02459
• MDR Report Key: 25678539
• Report Number: 3015537318-2026-00068
• Device Sequence Number: 14632802
• Product Code: LKK
• UDI-Device Identifier: 00850014110147
• UDI-Public: 00850014110147
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P890055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/20/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2026
• Device Model Number: AP-03000H
• Device Catalogue Number: AP03000H
• Device Lot Number: 30455632
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Race: Asian