MAUDE Adverse Event Report: EPIC INTERNATIONAL (THAILAND) CO; LTD SMARTEZ 100 ML, 200 ML/HR; PUMP, INFUSION, ELASTOMERIC

Model Number SE0200-100

Device Problem No Flow (2991)

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

Event Date 12/15/2018

Event Type  malfunction  

Event Description

Patient called and spoke with on-call nurse that he flushed iv line and attached smartez pump [se0200-100, lot: s8e46] filled with daptomycin 500 mg/0.9% sodium chloride 100 ml that would not infuse.Patient disconnected smartez pump, flushed again, and reconnected smartez pump and dose infused.

• Brand Name: SMARTEZ 100 ML, 200 ML/HR
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): EPIC INTERNATIONAL (THAILAND) CO; LTD
• MDR Report Key: 8206321
• MDR Text Key: 131969387
• Report Number: MW5082686
• 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: 12/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• 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: S8E46
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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