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

Model Number SE0200-100

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem Underdose (2542)

Event Date 08/09/2018

Event Type  malfunction  

Event Description

Smart ez pump (se0200-100, lot # s7l22) containing ertapenem 1 gram in 0.9% sodium chloride 100 ml did not finish infusing.Pt only received half of their dose.

• Brand Name: SMART EZ ELASTOMERIC INFUSION PUMP
• Type of Device: SMART EZ PUMP
• Manufacturer (Section D): EPIC INTERNATIONAL (THAILAND) CO., LTD. ; tasit; pluakdaeng, rayong 21140 ; TH 21140
• MDR Report Key: 7780296
• MDR Text Key: 117257523
• Report Number: MW5079107
• 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: 08/10/2018

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
• Device Lot Number: S7L22
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2018
• 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