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 03/17/2019

Event Type  malfunction  

Event Description

Smartez device containing cefazolin 2gm/ns 100ml (200/100ml, lot # unk, exp unk).Pt called and explained device would not infuse after over 30 mins.Pt unhooked device and attached a different smartez device and the device infused with no issues.

• Brand Name: SMARTEZ PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): EPIC INTERNATIONAL (THAILAND) CO., LTD. ; tasit; pluakdaeng, rayong 21140 S; TH 21140S
• MDR Report Key: 8436339
• MDR Text Key: 139372276
• Report Number: MW5085020
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): Y
• 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: 03/18/2019

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 Model Number: SE0200-100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/19/2019
• Patient Sequence Number: 1