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

Model Number SE0200-100

Device Problem Failure to Infuse (2340)

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

Event Date 12/20/2018

Event Type  malfunction  

Event Description

Two smartez pumps [sec200-100; lot: 8se46] filled with cefazolin 2 g/0.9% sodium chloride 100 ml did not infuse.Patient's son called on-call rn and rn suggested that he position patient sitting up to infuse rather than lying down.Son agreed and would call back if smartez did not infuse.No return call.Patient went to infusion center and md offered patient to be admitted to hospital, which patient accepted.

• Brand Name: SMARTEZ PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): EPIC INTERNATIONAL (THAILAND) CO. LTD
• MDR Report Key: 8222193
• MDR Text Key: 132491851
• Report Number: MW5082867
• Device Sequence Number: 2
• 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: 01/03/2019
• 2 Devices were Involved in the Event: 1 2

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 Model Number: SE0200-100
• Device Lot Number: 8SE46
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/04/2019
• 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