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

Model Number SE0200-100

Device Problem Improper Flow or Infusion (2954)

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

Event Type  No Answer Provided  

Event Description

Smartez pump (se0220-100, lot# s8m32, exp.10/28/2021) containing ceftriaxone 2 grams in 0.9% sodium chloride 100 ml took 1.5 hours to infuse.Fda safety report id# (b)(4).

• Brand Name: SMARTEZ ELASTOMERIC INFUSION PUMP
• Type of Device: PUMP, INFUSION, ELASTOMETRIC
• Manufacturer (Section D): EPIC INTERNATIONAL ( THAILAND) CO. LTD.
• MDR Report Key: 8860961
• MDR Text Key: 153417211
• Report Number: MW5088732
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 10/28/2021
• Device Model Number: SE0200-100
• Device Lot Number: S8M32
• Was Device Available for Evaluation?: 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