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

Model Number	484011
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device history record for the reported lot number was reviewed and confirmed that the lot was manufactured according to approved manufacturing procedures.Retained samples were also tested and passed.
Event or Problem Description
On 05/22 - pt connected to disposable infusion device (smart z) for 46 hrs.Infusion of fluorouracil.Pt returned to infusion suite am 05/23 after noting visible blood in tubing from port needle site to infusion pump.Wrapping had been applied to site of needle/pump connection at time placed 05/22 to insure tight connection.At time of arrival to cho, tape noted wet with 5fu residue present on pt's upper abdomen.All clamps examined and were open.Physician notified, pharmacy recalibrated dose for 24 hr 5fu infusion.Pt discharged to home with infusion via cadd pump.

• Brand Name: SMARTEZ PUMP
• Common Device Name: ELASTOMERIC INFUSION PUMP
• Manufacturer (Section D): EPIC INTERNATIONAL (THAILAND) CO., LTD.; hemaraj eastern seaboard; industrial estate 500/73; moo 2, tasit pluak daeng, rayong 21140 ; TH 21140
• MDR Report Key: 9801645
• Report Number: 3012429465-2020-00003
• Device Sequence Number: 16663628
• Product Code: MEB
• UDI-Device Identifier: 18859299104017
• UDI-Public: (01)18859299104017(10)C8M04(17)211018(11)181128(241)SE0002-100C
• Combination Product (Y/N): N
• PMA/510(K) Number: K1501650
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• 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: 484011
• Device Lot Number: C8M04
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2020
• 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