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

Model Number AP03000H

Device Problem Filling Problem (1233)

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

Event Date 09/15/2022

Event Type  malfunction  

Event Description

An intera 3000 hepatic artery infusion pump was explanted on (b)(6) 2022.Implant date was reported as (b)(6) 2022.It was reported by a healthcare professional that the device was explanted due to resistance in infusing the device.On (b)(6) 2022, the device was infused with 23 ml of infusate and on (b)(6) 2022, the device returned 18 ml of infusate.The infusion team refilled the device with 21 ml of infusate before resistance was met.The device was explanted with the request to return to intera oncology for investigation, but the device has not yet been returned at the time of this report.

Manufacturer Narrative

The device has been requested to be returned for evaluation, but has not yet been shipped by the customer as of the time of this report.If further information is received at a later date, a supplemental report will be filed.

Manufacturer Narrative

Device returned and evaluated.Reference mw5113423.Evaluation of the device confirmed a defect but unable to trace specifically to the root cause.The device met all manufacturing specifications prior to release.The device initially failed crimp leak test and was recrimped per the allowable procedure.This serial number was sampled for pyrogen testing and then returned to the lot.The recrimp and the pyrogen testing are both allowable procedures and not considered to impact the device performance as it relates to the complaint.There were two ncmrs for the lot pertaining to the sterilization cycle and bioburden testing.First, the bioburden testing exceeded allowable levels, therefore the lot was dispositioned on ncmr and resampled and resterilized.The second sterilization cycle did not meet specification, and therefore was dispositioned on ncmr the lot was resterilized a second time, for a total of three sterilization cycles.Sterilization is allowed up to 3 times per the approved manufacturing procedure.

Event Description

An intera 3000 hepatic artery infusion pump was explanted on (b)(6) 2022.Implant date was reported as (b)(6) 2022.It was reported by a healthcare professional that the device was explanted due to resistance in infusing the device.On (b)(6) 2022, the device was infused with 23 ml of infusate and on (b)(6) 2022, the device returned 18 ml of infusate.The infusion team refilled the device with 21 ml of infusate before resistance was met.The device was explanted with the request to return to intera oncology for investigation, but the device has not yet been returned at the time of this report.

• 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: 15589326
• MDR Text Key: 301593556
• Report Number: 3015537318-2022-00020
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• 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: 28723S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2022
• 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: 28 YR
• Patient Sex: Male
• Patient Weight: 90 KG