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	10/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided did not specify the location of leak.Root cause is unknown.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
Two smartez pumps (model# se0200-100, lot# s8e20) containing cefepime 2 grams / 0.9% , sodium chloride 100 ml leaked.100ml,200 ml/hr.

• 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: 8147437
• Report Number: 3012429465-2018-00010
• Device Sequence Number: 16515860
• 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
• 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 Expiration Date: 04/28/2021
• Device Model Number: 481012
• Device Lot Number: S8E20
• 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