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

Model Number C270-5-54H

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 02/22/2023

Event Type  malfunction  

Event Description

While attempting to inject 0.9% nacl into a smartez pump fill port the port "cracked", leaking fluid out.This happened a total of 2 different attempts using 2 pumps on (b)(6) 2023.Reference report mw5115360.

• Brand Name: SMART EZ PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): EPIC INTERNATIONAL (THAILAND) CO., LTD
• MDR Report Key: 16467227
• MDR Text Key: 310723487
• Report Number: MW5115359
• 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: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C270-5-54H
• Device Catalogue Number: 484041
• Device Lot Number: C22G004
• Was Device Available for Evaluation?: Yes
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 43 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White