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

Model Number 481012

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Type  malfunction  

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 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
• 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 drive; hampton, va 23666 ; 7572240177
• MDR Report Key: 8147456
• MDR Text Key: 129901666
• Report Number: 3012429465-2018-00006
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 28859299101013
• UDI-Public: (01)28859299101013
• 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

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