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

Model Number AP03000H

Device Problem Use of Device Problem (1670)

Patient Problem Hyperbilirubinemia (1903)

Event Date 06/20/2023

Event Type  Injury  

Manufacturer Narrative

No device deficiency was alleged.The intera 3000 hepatic artery infusion pump ifu discusses calculations of flow rate and refill intervals.Blank information in the mdr form represents unknown information.If further information is received at a later date, a supplemental report will be filed.

Event Description

It was reported by a healthcare provider did not schedule a patient to come back to have his pump refilled following the memorial day holiday.The patient has an intera 3000 hepatic artery infusion pump, implant date was (b)(6) 2023.Because the patient was not rescheduled for the typical 2 week interval, the patient received all 30 ml of floxuridine/dex/hep saline.The patient returned 3.5 weeks later with a dry pump.They were able to refill it then, however the patient presented a week later with significant hepatotoxicity and a bilirubin of 20.He needed to have a shunt placed.He now has hep/saline and dex in the pump.

• 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
• MDR Report Key: 17367526
• MDR Text Key: 319477523
• Report Number: 3015537318-2023-00025
• 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: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: AP03000H
• Device Catalogue Number: AP-03000H
• Device Lot Number: 28880
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2022
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Race: White