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

Model Number SE0200-100

Device Problems Failure to Infuse (2340); Defective Device (2588)

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

Event Date 08/10/2018

Event Type  malfunction  

Event Description

Pt called and said that her daptomycin ed is not infusing.She has had it hooked up for 2 hours and is not emptying.She said the picc flushes with ease and all clamps are opened.Smartez pump ((b)(4)) containing daptomycin 600 mg in 0.9% sodium chloride 100 ml.Pt discarded defective infusion device, therefore lot number unavailable.

• Brand Name: SMARTEZ ELASTOMERIC INFUSION PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): EPIC INTERNATIONAL (THAILAND CO., LTD.); tasit; pluakdaeng, rayong 21140 ; TH 21140
• MDR Report Key: 7801684
• MDR Text Key: 117899816
• Report Number: MW5079261
• 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: 08/16/2018

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/20/2018
• 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