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

Model Number SE0200-100

Device Problems Deflation Problem (1149); Inaccurate Flow Rate (1249)

Patient Problem No Information (3190)

Event Date 01/19/2019

Event Type  malfunction  

Event Description

One (1) smartez pump (se0200-100, lot# unknown) containing ampicillin- sulbactam 3g grams in 0.9% sodium chloride 100 ml slow infusion.Patient mentioned that one side of the ball deflated more than the other and it was extremely slow for infusion.

• Brand Name: SMARTEZ PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): EPIC INTERNATIONAL (THAILAND) CO., LTD.
• MDR Report Key: 8277973
• MDR Text Key: 134445240
• Report Number: MW5083392
• 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: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SE0200-100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1