MAUDE Adverse Event Report: EPIC INTERNATIONAL (THAILAND) CO. LTD SMARTEZ 100ML, 200 ML/HR USED WITH COMPOUNDED DRUG; PUMP, INFUSION, ELASTOMERIC

Model Number SE0200-100

Device Problem Particulates (1451)

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

Event Date 11/26/2018

Event Type  malfunction  

Event Description

Smartez pump (se0200-100, lot# s8d33) containing cefazolin 2 gram (batch rx # h938108, mix date 11/25/2018) in 0.9% sodium chloride 100 ml had a particulate floating in solution.

• Brand Name: SMARTEZ 100ML, 200 ML/HR USED WITH COMPOUNDED DRUG
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): EPIC INTERNATIONAL (THAILAND) CO. LTD; 144 research drive; hampton VA 23666
• MDR Report Key: 8129126
• MDR Text Key: 129577800
• Report Number: MW5081810
• 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: 11/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SE0200-100
• Device Lot Number: S8D33
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1