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

Model Number	484041
Health Effect - Clinical Codes	Overdose (1988); Test Result (2695)
Date of Event	07/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device history record for this lot did not show any flow rate issue.The evaluation on the returned device was performed on 2019-08-14 and result shows flow rate was 5.21 ml/h within claimed accuracy of +/- 15%.
Event or Problem Description
The patient was put on an elastomeric infusion pump on 7/23 at 1600 that was set to infuse 230ml over 46hrs rate approx 5ml/hr.The patient called the clinic at approximately 1000 on 7/24 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.In follow up conversation with ramiro, patient activity during this time was normal.Patient was not outside or involved in activity that would expose to high levels of heat.Patient didn't present with any additional symptoms to ramiro's knowledge, but lab work had been done which showed low white blood cell count.Due to patient and staff concerns the decision was made to administer vistogard treatment.

• Brand Name: SMARTEZ PUMP
• Common Device Name: ELASTOMERIC INFUSION PUMP
• Manufacturer (Section D): EPIC INTERNATIONAL (THAILAND) CO., LTD.; hemaraj eastern seaboard indus; 500/73 moo 2, tasit; pluak daeng rayong, 21140 ; TH 21140
• MDR Report Key: 9801648
• Report Number: 3012429465-2020-00002
• Device Sequence Number: 19352378
• Product Code: MEB
• UDI-Device Identifier: 18859299104048
• UDI-Public: (01)18859299104048(10)C8M65(17)211028(11)181128(241)SE0005-270C
• Combination Product (Y/N): N
• PMA/510(K) Number: K151650
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 03/05/2020

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: 484041
• Device Lot Number: C8M65
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2019
• Initial Report FDA Received Date: 03/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1