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	11/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device history record for this lot did not show any no flow rate issue.Retained samples were also subjected to flow test and the device flows normally.The information provided is insufficient for further investigation.A follow-up report will be submitted when the results of the investigation are available.
Event or Problem Description
Slow flow with vancomcyin 2 g/ns 250 ml smartez {seol75-250; lot: s8h02} and caftriaxone 2 g/ns 100ml smartez {se0200-100; lot s8d33}.{six (6) doses of vancomycin and four (4) doses of ceftriaxone had to be replaced); 100 ml, 200 ml /hr and smartez 250 ml.175 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: 8350429
• Report Number: 3012429465-2019-00035
• Device Sequence Number: 16678797
• Product Code: MEB
• UDI-Device Identifier: 28859299101068
• UDI-Public: (01)28859299101068(10)S8H02(17)210728(11)180828(241)SE0175-250
• 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: 07/28/2021
• Device Model Number: 481062
• Device Lot Number: S8H02
• 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