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

Model Number	481012
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the descriptions of the event by user facility, the device functions normally- as it flows when disconnected.Device history record for this lot did not show any no flow issue.Retained samples were also subjected to flow test and the device flows normally.
Event or Problem Description
Smartez pump (se0200-100, lot#s8c58) containing meropenem 1 gram in 0.09% sodium chloride 100ml would not infuse.When disconnected, it will drip.Tubing connected tightly, line flushing well.

• Brand Name: SMARTEZ PUMP
• Common Device Name: ELASTOMERIC PUMP
• Manufacturer (Section D): EPIC INTERNATIONAL (THAILAND) CO., LTD.; epic international (thailand); 500/73 moo 2, tasit; pluakdaeng, rayong 21140 ; TH 21140
• MDR Report Key: 8272149
• Report Number: 3012429465-2019-00026
• Device Sequence Number: 1259660
• Product Code: MEB
• UDI-Device Identifier: 28859299101013
• UDI-Public: (01)28859299101013(10)S8C58(17)210228(11)180328(241)SE0200-100
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/17/2019

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: 02/28/2021
• Device Model Number: 481012
• Device Lot Number: S8C58
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/03/2019
• Initial Report FDA Received Date: 01/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1