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

Model Number SE0175-250

Device Problems Leak/Splash (1354); Failure to Infuse (2340)

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

Event Date 12/25/2018

Event Type  malfunction  

Event Description

Smartez pumps (se0175-250, lot# s8h02 x3) containing vancomycin 1.5 gram in 0.9% sodium chloride 250 ml; 1 would not infuse, 1 was taking over 5 hours to infuse (both dripped when disconnected and unclamped), and 1 leaked out.

• Brand Name: SMARTEZ ELASTOMERIC INFUSION PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): EPIC INTERNATIONAL (THAILAND) CO., LTD.
• MDR Report Key: 8203121
• MDR Text Key: 131897171
• Report Number: MW5082667
• 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: 12/26/2018
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SE0175-250
• Device Lot Number: S8H02
• 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