MAUDE Adverse Event Report: EPIC INTERNATIONAL (THAILAND) CO., LTD. SMART EZ ELASTOMERIC INFUSION PUMP 270 ML; 5 ML/HR; PUMP, INFUSION, ELASTOMERIC

Model Number SE0005-270

Device Problem Insufficient Flow or Under Infusion (2182)

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

Event Type  malfunction  

Event Description

Progressive medical smart ez elastomeric infusion pump filled with fluorouracil to be infused over approximately 47 hours did not completely infuse for patient.The pump was hooked up to the patient on (b)(6) 2022 and when the patient returned to the clinic for pump removal on (b)(6) 2022, approximately 75% of the product was still in the pump and had not infused.The pump that was selected was the correct size with the appropriate volume and rate for the medication to be infused over approximately 47 hours.The pump was size 270ml, rate of 5 ml/hr, and lot: c21d019; model se0005-270.The total volume that was instilled into the pump was 233.5 ml.Fda safety report id# (b)(4).

• Brand Name: SMART EZ ELASTOMERIC INFUSION PUMP 270 ML; 5 ML/HR
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): EPIC INTERNATIONAL (THAILAND) CO., LTD.
• MDR Report Key: 14282590
• MDR Text Key: 290812303
• Report Number: MW5109495
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 04/29/2022

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 Model Number: SE0005-270
• Device Lot Number: C21D019
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/03/2022
• Patient Sequence Number: 1