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	11/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for evaluation.Visual inspection revealed that the particle was in solution.No other signs of abnormality were observed.The reported condition was verified.The cause of the condition was not determined.
Event or Problem Description
Smartez pump (se0200-100, lot# s8d33) containing cefazolin 2 gram (batch rx# h938108 , mix date (b)(6) 2018) in 0.9% sodium chloride 100 ml had a particulate floating in solution.

• 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: 8350422
• Report Number: 3012429465-2019-00030
• Device Sequence Number: 2229169
• Product Code: MEB
• UDI-Device Identifier: 28859299101013
• UDI-Public: (01)28859299101013(10)S8D33(17)210328(11)180428(241)SE0200-100
• 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: Other Health Care Professional
• 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: 03/28/2021
• Device Model Number: 481012
• Device Lot Number: S8D33
• Type of Report(Section G): Initial
• 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