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

Model Number 481062

Device Problem Insufficient Flow or Under Infusion (2182)

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

Event Type  malfunction  

Manufacturer Narrative

Based on the descriptions of the event by user facility, the cause of slow flow is probably due to poor connection with connector used on patient side.A tight connection is needed to open the fluid channel in the valve of some patient connectors.The pump flows normally when disconnected.

Event Description

Smartez pump (se0175-250, lot# unknown) containing telavancin 750 mg in 0.9% sodium chloride 250 ml took 8 hours to infuse.Patient line flushing fine.Ed drips quickly when disconnected and unclamped.Patient reconnected tightly without improvement.

• 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: 8350425
• MDR Text Key: 136865295
• Report Number: 3012429465-2019-00040
• Device Sequence Number: 1
• Product Code: MEB
• 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: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 481062
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2019
• 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