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

Model Number SE0200-100

Device Problem Insufficient Flow or Under Infusion (2182)

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

Event Date 04/03/2019

Event Type  No Answer Provided  

Event Description

Smartez ed device (lot s8c39, exp 02/28/2021) containing daptomycin 750mg/ns 100ml infused over 30 mins.Pt expressed issues with slow flow.Pt stated he infused for over an hour and infusion finally started flowing eventually.Fda safety report id# (b)(4).

• Brand Name: SMARTEZ PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): EPIC INTERNATIONAL (THAILAND) CO., LTD. ; tasit; pluankdaeng, rayong 21140 TH; TH 21140 TH
• MDR Report Key: 8496588
• MDR Text Key: 141505876
• Report Number: MW5085670
• 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: 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2021
• Device Model Number: SE0200-100
• Device Lot Number: S8C39
• Was Device Available for Evaluation?: No
• 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