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

Model Number	SE0005-270C
Health Effect - Clinical Code	Overdose (1988)
Date of Event	07/23/2019
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): EPIC INTERNATIONAL (THAILAND) CO. LTD.
• MDR Report Key: 8865855
• Report Number: MW5088804
• Device Sequence Number: 311052
• Product Code: MEB
• UDI-Device Identifier: 18859299104048
• UDI-Public: (01)18859299104048
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Weight: 75