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

Model Number SE0200-100

Device Problem Failure to Deliver (2338)

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

Event Date 07/25/2019

Event Type  malfunction  

Event Description

Smartez pump (se0200-100, lot#s8m32, exp.10/28/2021) containing 2 grams in 0.9% sodium chloride 100 ml stopped infusion prematurely.Fda safety report id# (b)(4).

• Brand Name: SMARTEZ ELASTOMERIC INFUSION PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): EPIC INTERNATIONAL (THAILAND) CO. LTD.; tasit, pluakdaeng, rayong 21140 ; TH 21140
• MDR Report Key: 8861314
• MDR Text Key: 153845821
• Report Number: MW5088753
• 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: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/28/2021
• Device Model Number: SE0200-100
• Device Lot Number: S8M32
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/02/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1