MAUDE Adverse Event Report: EPIC INTERNATIONAL (THAILAND) CO., LTD. EPIC SMARTEZ INFUSION PUMP; PUMP, INFUSION, ELASTOMERIC

Catalog Number 484041

Device Problems Failure to Infuse (2340); Defective Device (2588)

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

Event Date 02/28/2023

Event Type  malfunction  

Event Description

Ambulatory elastomeric pump (smartez) containing fluorouracil was connected to the patient in the clinic on (b)(6) 2023 to be infused over 48 hours.On (b)(6) 2023 patient called the clinic back stating that pump was not infusing and the medication bulb has not decreased in size.Patient was asked to come back to clinic for evaluation.In the clinic on (b)(6) 2023 pump and all connections were checked by nursing staff and pharmacist.All lines where properly attached, not clamped, and kink-free.When tubing was disconnected from patient to check for any flow, no medication flowed from the pump although the line was open.It seems the pump was not infusing any medication at all, which resulted in an unintended delay in chemotherapy administration.This seems to be a pump product defect.The issue was reported to the manufacturer.Our clinic had these pumps in use for more than a year and this is the first time we are encountering this issue.

• Brand Name: EPIC SMARTEZ INFUSION PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): EPIC INTERNATIONAL (THAILAND) CO., LTD.
• MDR Report Key: 16513105
• MDR Text Key: 311045319
• Report Number: MW5115589
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 484041
• Device Lot Number: C22G004
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/08/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FLUOROURACIL 02/27/2023-03/01/2023
• Patient Outcome(s): Other