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

Model Number 480041

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Overdose (1988)

Event Date 01/11/2020

Event Type  malfunction  

Manufacturer Narrative

Device history record for this lot did not show any flow rate issue.This is confirmed by flow rate testing on retained samples on 2020-02-11.A follow-up report will be submitted when the results of the investigation are available.

Event Description

Patient reported that smartez pump that should have infused over 24 hr completed in about 12 hrs.Medication dispensed in the 10ml/hr, 270ml fill smartez pump.The facility retrieved seven pumps from the patient.One ran fast, the remaining were retrieved for qa.Seven devices available for evaluation.(although awareness date was 1/11, complete information was not available til 1/24).

• Brand Name: SMARTEZ PUMP
• Type of Device: ELASTOMERIC INFUSION PUMP
• Manufacturer (Section D): EPIC INTERNATIONAL (THAILAND) CO., LTD.; hemaraj eastern seaboard; industrial estate 500/73; moo 2, tasit pluak daeng, rayong 21140 ; TH 21140
• Manufacturer (Section G): EPIC INTERNATIONAL (THAILAND) CO., LTD.; hemaraj eastern seaboard; industrial estate 500/73; moo 2, tasit pluak daeng, rayong 21140 ; TH 21140
• Manufacturer Contact: david lennarz ; 144 research dr; hampton , va 23666; 2240177
• MDR Report Key: 9801646
• MDR Text Key: 221855763
• Report Number: 3012429465-2020-00001
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 18859299100040
• UDI-Public: (01)18859299100040(10)S9B30(17)220128(11)190228(241)SE0010-270
• Combination Product (y/n): N
• PMA/PMN Number: K151650
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial
• Report Date: 03/05/2020

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: 01/28/2022
• Device Model Number: 480041
• Device Lot Number: S9B30
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/28/2020
• Initial Date FDA Received: 03/06/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/28/2019
• 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