MAUDE Adverse Event Report: EPIC INTERNATIONAL (THAILAND) CO., LTD. SMARTEZ ELASTOMERIC INFUSION DEVICE; 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 07/30/2019

Event Type  malfunction  

Event Description

Two (2) smartez pumps (se0200-100, lot # unk) containing zosyn 4.5 grams in 0.9% sodium chloride 100 ml would not infuse.Patient discarded.Fda safety report id # (b)(4).

• Brand Name: SMARTEZ ELASTOMERIC INFUSION DEVICE
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): EPIC INTERNATIONAL (THAILAND) CO., LTD. ; tasit; pluakdaeng, rayong 21140 TH; TH 21140 TH
• MDR Report Key: 8883469
• MDR Text Key: 154119881
• Report Number: MW5088941
• 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: 08/07/2019
• 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2019
• 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