MAUDE Adverse Event Report: EPIC INTERNATIONAL (THAILAND) CO. LTD. SMARTEZ PUMP C270-10-27H; PUMP, INFUSION, ELASTOMERIC

Model Number C270-10-27H

Device Problem Improper Flow or Infusion (2954)

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

Event Date 03/25/2019

Event Type  malfunction  

Event Description

Smart-ez pump from epic-med, product (c270-10-27h).Product was used for 24 hour chemotherapy.The pump was calibrated to discharge over 22 hours.Patient began therapy on (b)(6) 2019 and returned on (b)(6) 2019, when the unit should have been fully empty.The unit was still filled to more than half the original volume.The patient was asked to return on (b)(6) 2019 due to the weekend, but on their return the unit was still not fully emptied.This resulted in incomplete delivery of chemotherapy.

• Brand Name: SMARTEZ PUMP C270-10-27H
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): EPIC INTERNATIONAL (THAILAND) CO. LTD.
• MDR Report Key: 8459791
• MDR Text Key: 140442608
• Report Number: MW5085266
• 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: 03/25/2019

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: 10/28/2021
• Device Model Number: C270-10-27H
• Device Catalogue Number: 484051
• Device Lot Number: C8M29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/27/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Weight: 86