MAUDE Adverse Event Report: INTERA ONCOLOGY HEPATIC ARTERY INFUSION PUMP SINGLE CHAMBER; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number AP03000H

Device Problems Defective Component (2292); Inaccurate Delivery (2339)

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

Event Date 09/15/2022

Event Type  malfunction  

Event Description

(b)(4) single chamber pump reservoir was not emptying properly.Patient arrived on (b)(6) 2022 for his first dose of hepatic arterial infusion (hai) floxuridine (fudr) via the intera pump.It took multiple attempts to access the patient's intera pump.A test was performed that led the medical team to identify the issue was located within the chamber of the pump.Fda safety report id# (b)(4).

• Brand Name: HEPATIC ARTERY INFUSION PUMP SINGLE CHAMBER
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): INTERA ONCOLOGY; wellesley MA 02481
• MDR Report Key: 15844185
• MDR Text Key: 304423589
• Report Number: MW5113423
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2023
• Device Model Number: AP03000H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2022
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 28 YR
• Patient Sex: Male