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

Model Number SE0175-250

Device Problem Improper Flow or Infusion (2954)

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

Event Date 09/26/2018

Event Type  malfunction  

Event Description

Pt's husband reported 3 smartez pumps (se0175-250, lot # s8h11) containing vancomycin 750 mg in 0.9% sodium chloride 250 ml would not infuse the dose.Patient¿s picc line flushes easily and medication drips from the ed when opened, but not when connected to the picc.Verified that all clamps on the ed and the picc were open when attempting to infuse.

• Brand Name: SMARTEZ ELASTOMERIC INFUSION PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): EPIC INTERNATIONAL (THAILAND) CO., LTD. ; 144 research dr; hampton VI 23666
• MDR Report Key: 7929883
• MDR Text Key: 122803162
• Report Number: MW5080297
• 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: 10/01/2018
• 3 Devices were Involved in the Event: 1 2 3

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: SE0175-250
• Device Lot Number: S8H11
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/02/2018
• 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