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

Model Number AP3000H

Device Problem Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Date 12/15/2022

Event Type  Injury  

Event Description

An intera 3000 hepatic artery infusion pump was explanted due to infection.Initial implant date was (b)(6) 2022.The organism was identified as staphylococcus on (b)(6) 2022 and the device was explanted and replaced with a new device same day.In the physicians opinion, there was no causal relationship between the device and the infection.

Manufacturer Narrative

The pump expiration date was 02/28/2024, based on the packaged pump subassebly and sterilization date.The overall package assembly exipration date was 10/31/2022, which was based on the co-packaged accessories.Additional accessories were made available to the customer so that only non-expired product was used in the initial surgery.The complaint does not directly allege a device deficiency; sterilization records were reviewed and the product was determined acceptable for release.Total calculated bioburden for the 3 pumps tested in the lot was determined to be less than 2.8 cfu/sip in the inner reservoir, less than 2 cfu/sip for the outer effluent, and 2cfu/sip for the inner tray.Staphylococcus is published as a possible hospital-acquired infection.The physician does not allege a relationship between the device and the infection.Infection is a known adverse event as published in the intera 3000 ifu.If further information is received at a later date, a supplemental mdr will be filed.Blank fields in the mdr report represents unknown information.

• 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: 16091827
• MDR Text Key: 306592266
• Report Number: 3015537318-2023-00001
• 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: 01/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: AP3000H
• Device Catalogue Number: AP-03000H
• Device Lot Number: 28578
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2022
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 81 KG