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

Model Number 481012

Device Problem Failure to Infuse (2340)

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

Event Date 11/19/2018

Event Type  malfunction  

Manufacturer Narrative

Device history record for this lot did not show any no flow issue.Retained samples were also subjected to flow test and the device flows normally.

Event Description

Smartez pump se0200-100, lot # s8c58) containing zosyn 4.5 grams in 0.9% sodium chloride 100 mls would not infuse.Patient's line flushing normally and line connected tightly.

• 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: 8272151
• MDR Text Key: 133963789
• Report Number: 3012429465-2019-00039
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 28859299101013
• UDI-Public: (01)28859299101013(10)S8C58(17)210228(11)180328(241)SE0200-100
• Combination Product (y/n): N
• PMA/PMN Number: K151650
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial
• Report Date: 01/17/2019

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: 02/28/2018
• Device Model Number: 481012
• Device Lot Number: S8C58
• Initial Date Manufacturer Received: 01/03/2019
• Initial Date FDA Received: 01/23/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/28/2018
• 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