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	05/11/2026
Type of Reportable Event	Malfunction
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 may 14, 2026, intera oncology shipped a return kit to retrieve the device for evaluation.As of today, we are waiting for the device to arrive.Therefore, once the device arrives and is evaluated, a supplemental report will be submitted.
Event or Problem Description
Intera oncology was notified of a device issue during pump preparation prior to implantation.An intera field representative provided on-site support.During operating room preparation, the scrub nurse successfully emptied, refilled, and flushed the pump at a fluid warmer setting of 120°f.Bead formation was observed at this temperature.When the fluid warmer temperature was reduced to 95°f, it was noted that at approximately 109°f the pump was no longer producing a bead.The intera field representative contacted the intera medical science liaison (msl) for guidance.Per instruction, the catheter pathway was re-flushed using the special bolus needle and observed for approximately 10 minutes; no bead formation occurred.A small additional portion of the catheter was then trimmed, the catheter pathway was re-flushed, and the fluid warmer temperature was increased to 120°f.An insufficient bead formed but did not develop into a full bead after approximately 15 minutes.The intera msl and an additional intera representative were consulted regarding the event.Following discussion, it was recommended that a backup pump (serial number (b)(6)) be opened and prepared.The backup pump was successfully prepared, demonstrated adequate bead formation without issue, and was subsequently implanted.

• 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: 25446146
• Report Number: 3015537318-2026-00062
• Device Sequence Number: 13127769
• Product Code: LKK
• UDI-Device Identifier: 00850014110147
• UDI-Public: 00850014110147
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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 Expiration Date: 09/30/2026
• Device Model Number: AP-03000H
• Device Catalogue Number: AP03000H
• Device Lot Number: 30766679
• 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: 05/12/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/09/2026
• Supplement Report FDA Received Date: 08/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2024
• 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
• Patient Sex: Unknown