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

Model Number AP03000H

Device Problems Infusion or Flow Problem (2964); No Flow (2991)

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

Event Date 12/13/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned to intera oncology on (b)(6) 2022 and evaluated under a testing protocol.The preliminary results demonstrate that the device was able to be prepped and flowed accordingly within manufacturing specification.The complaint could not be reproduced and therefore could not be confirmed via the device evaluation.The device history record was reviewed and there were no deviations or nonconformances pertaining to this device, all specifications were met at the time of manufacture.A supplemental mdr will be filed upon final results of the testing.Blank spaces in the mdr form represent unknown information at the time of this filing.If further information is received at a later date, a supplemental report will be filed.

Event Description

It was reported by a healthcare provider that an intera 3000 hepatic artery infusion pump was prepped with the required steps.The clinician reported that the pump would not bead during prep as expected.The clinician increased the temperature of solution warmer from 95f up to 120f to attempt to increase the flow.They used low dose heparinized saline to flush the catheter, decreased temperature to 95 f, and waited 10 minutes and pump did not bead.The temperature of the solution warmer was increased back up to 120 f, then they emptied the pump, injected 5 ml of saline in, 1 ml returned at a significantly slow rate.The surgeon ultimately decided to use a new pump in place of this pump.A new pump was opened, prepped, and implanted.No patient injury was reported.

Manufacturer Narrative

The testing to evaluate the device was completed and the final results demonstrated that the device was able to be prepped and flowed accordingly within manufacturing specification.The complaint could not be reproduced and therefore could not be confirmed via the device evaluation.

Event Description

It was reported by a healthcare provider that an intera 3000 hepatic artery infusion pump was prepped with the required steps.The clinician reported that the pump would not bead during prep as expected.The clinician increased the temperature of solution warmer from 95f up to 120f to attempt to increase the flow.They used low dose heparinized saline to flush the catheter, decreased temperature to 95 f, and waited 10 minutes and pump did not bead.The temperature of the solution warmer was increased back up to 120 f, then they emptied the pump, injected 5 ml of saline in, 1 ml returned at a significantly slow rate.The surgeon ultimately decided to use a new pump in place of this pump.A new pump was opened, prepped, and implanted.No patient injury was reported.

• 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: 16141480
• MDR Text Key: 308628348
• Report Number: 3015537318-2023-00003
• 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,Followup
• Report Date: 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2023
• 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: 28835
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2022
• 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