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

Model Number SE0200-100

Device Problem Leak/Splash (1354)

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

Event Date 12/11/2018

Event Type  malfunction  

Event Description

Smartez pump (se0200-100, lot # s8e46) containing ertapenem 1 gram in 0.9% sodium chloride 100 ml leaking at filter.

• Brand Name: SMARTEZ ELASTOMERIC INFUSION PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): EPIC INTERNATIONAL (THAILAND) CO., LTD.; 144 research dr.; hampton VA 23666
• MDR Report Key: 8174789
• MDR Text Key: 131135090
• Report Number: MW5082194
• 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: 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SE0200-100
• Device Lot Number: S8E46
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/17/2018
• 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