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

Lot Number C8L11

Device Problems Deflation Problem (1149); No Flow (2991)

Patient Problem Missed Dose (2561)

Event Date 09/05/2019

Event Type  malfunction  

Event Description

Smart ez pump (5 fu) to infuse over 48 hours.Patient returned after 48 hours with pump noted not be deflating.Pump appeared to be full meaning patient did not receive any of the 5fu of fluorouracil as prescribed.Fda safety report id # (b)(4).

• Brand Name: SMART EZ DISPOSABLE ELASTOMERIC INF PUMP
• Type of Device: PUMP INFUSION ELASTOMERIC
• Manufacturer (Section D): EPIC INTERNATION (THAILAND) CO., LTD.
• MDR Report Key: 9008133
• MDR Text Key: 158639331
• Report Number: MW5089731
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2021
• Device Lot Number: C8L11
• Was Device Available for Evaluation?: Yes
• 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: 53 YR