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

Model Number AP03000H

Device Problem No Flow (2991)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/26/2023

Event Type  malfunction  

Event Description

An intera 3000 hepatic artery infusion pump was reported to not be flowing.The pump was implanted on (b)(6) 2022 with a labeled intra-arterial flow rate of 1.2 ml/day.It was reported that the patient is receiving heparin/saline cycles every two weeks.The associated nurse reported there were no [flow] issues until (b)(6) 2023.The physician injected cathflo (altepase) into pump on (b)(6) 2023 in order to clear any potential catheter clotting.On (b)(6) 2023, the pump was accessed without difficulty and 30 ml [infusate] returned.The pump was reported to be flush[ing] and flow[ing] fine, but the heparin saline is not leaving the pump anymore.The physician reported there is "no clot at the end of the catheter, i flushed it myself." it was speculated that during a refill, air may have been injected into the pump, which may block flow to the catheter.The physician was advised to attempt to clear any air in the pump using heat.The patient was rechecked for flow on (b)(6) 2023 and 30 ml of residual was returned, indicating no flow.A technetium 99 study was conducted on (b)(6)2023 and it was determined there was normal flow to the liver.The preliminary decision was then to explant and replace the pump.The clinician rechecked the pump on (b)(6) 2023 and returned 10 ml of infusate (calculated to be flowing at 1 ml/day).The pump was again checked on (b)(6) 2023 and returned 12 ml of infusate (calculated to be flowing at 1.3 ml/day).Therefore, the decision to explant was aborted and the pump remains implant/d and in use.

Manufacturer Narrative

The final assembly lot record was reviewed as a part of this investigation.There were no deviations or nonconformances pertaining to this serial number.The device met all specifications prior to release from manufacturing.It is speculated that the event is attributed to intermittent air blockage to the flow path; however, as the device was later reported to be flowing within specification and not explanted, it is undertermined the exact root cause of the event.The device remains implanted at the time of this report.If further information is received at a later date, a supplemental report will be filed.

• Brand Name: INTERA 3000
• Type of Device: HEPATIC ARTERY INFUSION PUMP
• Manufacturer (Section D): INTERA ONCOLOGY; 65 william street; suite 200; wellesley MA 02481
• Manufacturer (Section G): INTERA ONCOLOGY; 65 william street; suite 200; wellesley MA 02481
• Manufacturer Contact: sarah lapp ; 65 william street; suite 200; wellesley, MA 02481 ; 7814895724
• MDR Report Key: 16527052
• MDR Text Key: 311581454
• Report Number: 3015537318-2023-00009
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00850014110147
• UDI-Public: 00850014110147
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P890055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: AP03000H
• Device Catalogue Number: AP-03000H
• Device Lot Number: 28703
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Race: White