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

Model Number C100-2-50H

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/17/2018

Event Type  malfunction  

Event Description

A (b)(6) female with a history of cancer was seen in the chemotherapy infusion center for treatment.The pt was started on 5fu via a smart ez pump for home infusion.The pt called the next morning because she noticed the 5fu smart ezpump was leaking.She was told to come to the chemotherapy infusion center right away.Upon examination, a crack was noted at the connection between smartez pump and posiflow.Additionally, the male piece of the luer lock was broken off and lodged into posiflow.Photographs were taken.The mfr rep was notified.

• Brand Name: SMARTEZ PUMP
• Type of Device: ELASTOMERIC INFUSION PUMP
• Manufacturer (Section D): EPIC INTERNATIONAL (THAILAND) CO., LTD. ; TH
• MDR Report Key: 8101795
• MDR Text Key: 128425184
• Report Number: MW5081582
• 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: Nurse
• Type of Report: Initial
• Report Date: 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2021
• Device Model Number: C100-2-50H
• Device Catalogue Number: SE0002-100C
• Device Lot Number: C8K22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 66 YR