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

Model Number PMI ITEM# SE0005-270C

Patient Problem Chemical Exposure (2570)

Event Date 03/27/2024

Event Type  malfunction  

Event Description

Patient called clinic after finding white residue around the bulb of his 5fu elastomeric pump as well as along the seams of the fanny pack.(please see note from (b)(6), rn in apex for call details).Patient was instructed to clamp line and put pump and fanny pack into chemo spill kit bag and bring to the infusion center for assessment.Patient arrived and port was de-accessed.Upon inspection, there was white residue along the interior and exterior seams of the fanny pack and white flecks around the bulb of the pump.There was visible chemo still in the bulb but no liquid in the spill kit bag.No obvious holes in bulb or issues with connections.Pump and fanny pack given to pharmacy.Discussed with patient's oncologist, dr.(b)(6) and pharmacy.Pharmacy calculated that the total pump volume was around 243.5 ml and patient received approximately 130 ml before pump was clamped.Decision was made to hold off on replacement dose at this time.Confirmed with oncology-infusion pump supervisor that ~20 ml leaked from pump.This occurred after the pump was already connected and when the patient was at home.

• Brand Name: SMARTEZ® ELASTOMERIC INFUSION PUMPS
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): EPIC INTERNATIONAL (THAILAND) CO., LTD.; sg
• MDR Report Key: 19207833
• MDR Text Key: 341505700
• Report Number: MW5154397
• 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: 04/24/2024

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 Model Number: PMI ITEM# SE0005-270C
• Device Catalogue Number: 484041
• Device Lot Number: C23A055
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/26/2024
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 96 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White