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

Model Number 481012

Device Problem Failure to Infuse (2340)

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

Event Date 12/11/2018

Event Type  malfunction  

Manufacturer Narrative

Based on the descriptions of the event by user facility, the device functions normally.The initial observation of no flow could be due to poor connection with connector used on patient side.Device history record for the reported lot number was reviewed and confirmed that the lot was manufactured according to the approved manufacturing procedures.Retained samples were also tested and flow normally.

Event Description

Smartezpump (se0200-100,lot# s8e46) containing ertapenem 1 gram in 0.9% sodium chloride 100ml would not infuse after 20 minutes.Picc line flushing without problem.Ed is dripping when disconnected and unclamped.

• Brand Name: SMARTEZ PUMP
• Type of Device: ELASTOMERIC 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: 8350408
• MDR Text Key: 136618806
• Report Number: 3012429465-2019-00056
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 28859299101013
• UDI-Public: (01)28859299101013(10)S8E46(17)210428(11)180528(241)SE0200-100
• 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
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2021
• Device Model Number: 481012
• Device Lot Number: S8E46
• Initial Date Manufacturer Received: 01/15/2019
• Initial Date FDA Received: 02/19/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/28/2018
• 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