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

Model Number 481062

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/25/2018

Event Type  malfunction  

Manufacturer Narrative

Based on the descriptions of the event by user facility, the cause for leaks may be due to the folding of the outer cover that prevents the caps from being secured properly.There is no patient involvement reported.There is no adverse event.

Event Description

Tech using repeater pump to fill smartez pump ((b)(4), lot# s8h02) with 0.9% sodium chloride and fluid began leaking out at base of elastomeric device.

• Brand Name: SMARTEZ PUMP
• Type of Device: 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
• Manufacturer (Section G): EPIC INTERNATIONAL (THAILAND) CO., LTD.; hemaraj eastern seaboard indus; 500/73 moo 2, tasit; pluakdaeng, rayong 21140 ; TH 21140
• Manufacturer Contact: david lennarz ; registrar corp; 144 research dr; hampton , va 23666 ; 7572240177
• MDR Report Key: 8147444
• MDR Text Key: 130061143
• Report Number: 3012429465-2018-00007
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 28859299101068
• UDI-Public: (01)28859299101068
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151650
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2021
• Device Model Number: 481062
• Device Lot Number: S8H02
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2018
• Initial Date FDA Received: 12/10/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1