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

Model Number SE0002-100C

Device Problems Failure to Infuse (2340); Pumping Problem (3016)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/30/2022

Event Type  malfunction  

Event Description

Patient was receiving fluorouracil over 48 hours via an elastomeric pump.The pump malfunctioned and the medication did not infuse.Fda safety report id# (b)(4).

• Brand Name: SMARTEZ PUMP ELASTOMERIC PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): EPIC INTERNATIONAL (THAILAND) CO., LTD.
• MDR Report Key: 15042971
• MDR Text Key: 296134149
• Report Number: MW5110907
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SE0002-100C
• Device Lot Number: C21M002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White