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

Model Number	484011
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	10/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device history record for this lot did not show any issue related to broken luer lock.Retained samples were also subjected to luer lock functional test and there is no leakage.A follow-up report will be submitted when the results of the investigation are available.
Event or Problem Description
A (b)(6) male with a history of cancer was seen in the chemotherapy infusion center for treatment.The pt was started on 5fu via a smart ez pump for home infusion.The next morning the pt called the chemotherapy infusion center , and stated."something is wrong with the pump." the pt was instructed to come to the chemotherapy infusion center right away.When the pt arrived, the pump was leaking on his body.The pt cleaned.The leak was noted to be at the connection between smartez pump and posiflow.The male piece of the luer lock end of the smartez pump was found to be broken off and lodged in the posiflow.Pictures were taken and the mfr rep was notified.

• Brand Name: SMARTEZ PUMP
• Common Device Name: ELASTOMERIC PUMP
• Manufacturer (Section D): EPIC INTERNATIONAL (THAILAND) CO., LTD.; hemaraj eastern seaboard indus; 500/73 moo 2, tasit; pluakdaeng, rayong 21140 ; TH 21140
• MDR Report Key: 8350444
• Report Number: 3012429465-2019-00029
• Device Sequence Number: 19234045
• Product Code: MEB
• UDI-Device Identifier: 18859299104017
• UDI-Public: (01)18859299104017(10)C8K22(17)210828(11)180928(241)SE0002-100C
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/25/2019

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: 08/28/2021
• Device Model Number: 484011
• Device Lot Number: C8K22
• Type of Report(Section G): Periodic
• Initial Date Received by Manufacturer: 01/03/2019
• Initial Report FDA Received Date: 02/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1