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 10/17/2018

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 site.

Event Description

Smartez200 ml/hr 100 ml volume (lot# unknown) filled with imipenem/cilastatin 500 mg, would not infuse when attached to the patient's iv catheter.It drip ped when not connected to the patient.Patient was able to infuse with another smartez dose.

• Brand Name: SMARTEZ PUMP
• Type of Device: ELASTOMERIC PUMP
• Manufacturer (Section D): EPIC INTERNATIONAL (THAILAND) CO., LTD.; epic international (thailand); 500/73 moo 2, tasit; pluakdaeng, rayong 21140 ; TH 21140
• Manufacturer (Section G): EPIC INTERNATIONAL (THAILAND) CO., LTD.; epic international (thailand); 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: 8272153
• MDR Text Key: 134096056
• Report Number: 3012429465-2019-00044
• Device Sequence Number: 1
• Product Code: MEB
• 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 Model Number: 481012
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 01/03/2019
• Initial Date FDA Received: 01/23/2019
• 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