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

Model Number SE0005-270C

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Overdose (1988)

Event Date 07/23/2019

Event Type  Injury  

Event Description

The patient was put on an elastomeric infusion pump on 07/23 at 1600 that was set to infuse 230ml over 46hrs rate approx 5ml/hr.The patient called the clinic at approximately 1000 on (b)(6) stating that the pump looked smaller than normal.The pharmacist directed her to stop the pump from infusing.When she returned to the pharmacy the pump was drained and determined to have 48ml left out of the 230ml it was filled with.The calculations and compounding were verified to be correct.Based on the time and volume remaining the pump the rate of infusion was determined to be approximately 10ml/hr, double the stated rate.Over the course of 18 hours of infusion the patient received 3500mg of fluorouracil.The oncologist decided it was best to treat the patient with vistogard (uridine triacetate) the reversal drug for fluorouracil overdose.The patient received the drug in the 96 hour time frame and has not reported any additional side effects.The pharmacy has contacted the pump manufacturer about the device error.Fda safety report id# (b)(4).

• Brand Name: SMARTEZ PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): EPIC INTERNATIONAL (THAILAND) CO. LTD.
• MDR Report Key: 8865855
• MDR Text Key: 153706189
• Report Number: MW5088804
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 18859299104048
• UDI-Public: (01)18859299104048
• 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: 08/01/2019

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: Health Professional
• Device Expiration Date: 10/28/2021
• Device Model Number: SE0005-270C
• Device Catalogue Number: 484041
• Device Lot Number: C8M65
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/05/2019
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 75