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

Model Number	481012
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the descriptions of the event by user facility, the cause for leaks could be bonding between the tube and base of the device.There is no patient involvement reported.There is no adverse event.Additional attempts to get the sample are being made.A follow-up report will be submitted when the results of the investigation are available.
Event or Problem Description
Smartez pump (se0200-100.Lot# s8c58) containing cefazolin 2 grams in 0.9% sodium chloride 100 ml is leaking at the base of device.

• 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: 8147456
• Report Number: 3012429465-2018-00006
• Device Sequence Number: 13867527
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 02/28/2018
• Device Model Number: 481012
• Device Lot Number: S8C58
• 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