MAUDE Adverse Event Report: INTERA ONCOLOGY, INC Intera 3000; Hepatic Artery Infusion Pump

Model Number	AP-03000H
Medical Device Problem Codes	Inaccurate Delivery (2339); Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Intera oncology was notified of a pump preparation issue prior to implantation.The pump was placed in a sterile water warmer while awaiting surgeon preparation.When the user attempted to empty the pump reservoir, no fluid was returned.Per troubleshooting protocol, a 10 ml syringe containing low-dose heparinized saline was attached to the refill needle and approximately 5 ml was injected into the reservoir.Upon release of pressure, no fluid returned to the syringe and only air bubbles were observed.This troubleshooting step was repeated a second time with the same result.As no fluid return could be obtained, the pump was subsequently filled with high-dose heparinized saline according to the preparation procedure.Correct placement of the refill needle was confirmed after each 5 ml increment during filling.The pump was then flushed with low-dose heparinized saline per the preparation instructions.The sterile water warmer reached approximately 103°f.Historically, this temperature had not resulted in preparation issues at the facility.The clinical team waited for bead formation; however, an adequate bead did not develop.The surgeon independently assessed the pump, confirmed inadequate bead formation and flow, and determined that the pump was not functioning as expected.After waiting more than 20 minutes without adequate bead formation, the surgeon elected not to proceed with implantation due to concerns regarding pump flow and functionality.A second pump from separate inventory was opened and prepared using the same process.The second pump demonstrated appropriate flow and bead formation and was considered functional.
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.On june 10, 2026, intera oncology received the device for evaluation.As of today, the device is being investigated.Therefore, once the investigation is complete, a supplemental report will be submitted.

• 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: 25512971
• Report Number: 3015537318-2026-00065
• Device Sequence Number: 10165143
• Product Code: LKK
• UDI-Device Identifier: 00850014110147
• UDI-Public: 00850014110147
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P890055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AP-03000H
• Device Catalogue Number: AP03000H
• Device Lot Number: 32375490
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/10/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2026
• Supplement Date Received by Manufacturer: 08/04/2026
• Initial Report FDA Received Date: 06/15/2026
• Supplement Report FDA Received Date: 08/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2025
• 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
• Patient Sex: Unknown