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

Model Number SE0200-100

Device Problem No Flow (2991)

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

Event Date 12/21/2018

Event Type  malfunction  

Event Description

Three(e) smartez pumps [se0200-100, lot: s8e46, s8e45, s8c58] filled with daptomycin 550 mg/0.9% sodium chloride 100 ml would not infuse.Patient went to er to get iv line evaluation and dose.Iv line was okay.No doses missed.

• Brand Name: SMARTEZ 100 ML, 200 ML/HR
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): EPIC INTERNATIONAL (THAILAND) CO., LTD
• MDR Report Key: 8206316
• MDR Text Key: 131968309
• Report Number: MW5082685
• 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: 12/27/2018
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• 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
• 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