MAUDE Adverse Event Report: EPIC MEDICAL PTE LTD. SMARTEZ; PUMP, INFUSION, ELASTOMERIC

Model Number SE0200-100

Device Problem Failure to Deliver (2338)

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

Event Date 12/21/2018

Event Type  malfunction  

Event Description

On call rn received call from patient's wife reporting medication is not infusing.He had been connected for over 45 minutes and the ball had not decreased.She reported to on-call rn that she already flushed the line again and disconnected the tubing to check for drips 4 times.The smartez pump filled with ceftriaxone 2g/0.9% sodium chloride 100 ml dripped upon disconnection from iv line.Patient used another smartez pump and infused [smartez model # se0200-100, lot: s8e45].

• Brand Name: SMARTEZ
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): EPIC MEDICAL PTE LTD.
• MDR Report Key: 8206391
• MDR Text Key: 132083923
• Report Number: MW5082696
• 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

• 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: S8E45
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/28/2018
• 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