MAUDE Adverse Event Report: EPIC INTERNATIONAL (THAILAND) CO., LTD. / REGISTRAR CORP. SMARTEZ 100 ML, 200 ML/HR; PUMPM, INFUSION, ELASTOMERIC

Device Problem Failure to Infuse (2340)

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

Event Date 10/17/2018

Event Type  malfunction  

Event Description

Smartez 200 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 dripped when not connected to the patient.Patient was able to infuse with another smartez dose.

• Brand Name: SMARTEZ 100 ML, 200 ML/HR
• Type of Device: PUMPM, INFUSION, ELASTOMERIC
• Manufacturer (Section D): EPIC INTERNATIONAL (THAILAND) CO., LTD. / REGISTRAR CORP.
• MDR Report Key: 8146776
• MDR Text Key: 130025973
• Report Number: MW5081970
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 12/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1