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

Model Number	481012
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the descriptions of the event by user facility, the cause of no flow is probably due to poor connection with connector used on patient side.A tight connection is needed to open the fluid channel in the valve of some patient connectors.The pump flows normally when disconnected.
Event or Problem Description
Smartez 100 ml volume, 200 ml / hr, filled with ceftriaxone 2 grams/0.9% sodium chloride 100 ml, would not infuse through iv line, but would drip when disconnected.

• 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; pluakdaeng, rayong 21140 ; TH 21140
• MDR Report Key: 8147452
• Report Number: 3012429465-2018-00003
• Device Sequence Number: 16536471
• Product Code: MEB
• UDI-Device Identifier: 28859299101013
• UDI-Public: (01)28859299101013
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/04/2018

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 Model Number: 481012
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2018
• Initial Report FDA Received Date: 12/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1