MAUDE Adverse Event Report: EPIC MED / EPIC INTERNATIONAL (THAILAND) CO., LTD. SMARTEZ PUMP 10/270; PUMP, INFUSION, ELASTOMERIC

Model Number SE0010-270

Device Problem Inaccurate Delivery (2339)

Patient Problem Insufficient Information (4580)

Event Date 05/17/2021

Event Type  malfunction  

Event Description

We had a patient report his 24 hour pump infused over less than 24 hours (7 hours short at one point) and we remixed his medication with another lot number of the same type of pump.We did a test on one of the pumps and this pump started at 3:41pm yesterday was complete around 1pm.Just wanted to make someone aware we may have an issue with the pumps emptying too fast.Please everyone keep a watch on our 10/270 pumps and report any unusual findings.Fda safety report id # (b)(4).

• Brand Name: SMARTEZ PUMP 10/270
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): EPIC MED / EPIC INTERNATIONAL (THAILAND) CO., LTD.
• MDR Report Key: 11855352
• MDR Text Key: 252144250
• Report Number: MW5101473
• Device Sequence Number: 1
• Product Code: MEB
• 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: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SE0010-270
• Device Catalogue Number: SE0010-270
• 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