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

Model Number	481062
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigations on similar defective samples that were returned, the no flow events were due to kinked administration tube arising from clamping of the device.
Event or Problem Description
Two (2) smartez pumps (250 ml volume; 175 muhr) filled with vancomycin 1 g/0.9% sodium chloride would not infuse.Smartez pump lot: s8h11.Therapy start date: (b)(6) 2018.No patient involvement.

• 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: 8074954
• Report Number: 3012429465-2018-00001
• Device Sequence Number: 195067
• Product Code: MEB
• UDI-Device Identifier: 28859299101068
• UDI-Public: (01)28859299101068
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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
• Type of Report: Initial
• Report Date (Section B): 11/08/2018

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 Expiration Date: 07/28/2021
• Device Model Number: 481062
• Device Lot Number: S8H11
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2018
• Initial Report FDA Received Date: 11/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1