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

Lot Number S8A24

Device Problem Leak/Splash (1354)

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

Event Date 05/10/2019

Event Type  No Answer Provided  

Event Description

Four (4) smartez pump (se0200-100, lot# s8a24, exp: 12/28/2020) immediately began leaking at the mixing port during sterile compounding.Fda safety report id# (b)(4).

• Brand Name: SMARTEZ PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): EPIC INTERNATIONAL (THAILAND) CO., LTD.
• MDR Report Key: 8623849
• MDR Text Key: 145744900
• Report Number: MW5086735
• Device Sequence Number: 0
• 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: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• Device Operator: No Information
• Device Expiration Date: 12/28/2020
• Device Lot Number: S8A24
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1