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

Model Number 510K

Device Problems Improper Flow or Infusion (2954); Pumping Problem (3016)

Patient Problems Abdominal Pain (1685); Chest Pain (1776); Syncope/Fainting (4411)

Event Date 01/04/2023

Event Type  Death  

Event Description

Pt presented to cancer center for continuous infusion of 5 fu by elastomeric pump on (b)(6) 2023.Returned for disconnect on (b)(6) 2023 and reported that infusion completed in 5 hrs.Pt presented to emergency dept on (b)(6) 2022 with complaints of chest abdominal pain status post syncopal episode.Expired on (b)(6) 2022.

• Brand Name: SMARTEZ ELASTOMERIC PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): EPIC INTERNATIONAL (THAILAND) CO., LTD.
• MDR Report Key: 16246855
• MDR Text Key: 308246284
• Report Number: MW5114504
• 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: Nurse
• Type of Report: Initial
• Report Date: 01/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 510K
• Device Catalogue Number: SE0005-270C
• Device Lot Number: C22E043
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 64 YR
• Patient Sex: Male