MAUDE Adverse Event Report: EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED SMARTEZ PUMP; PUMP, INFUSION, ELASTOMERIC

Model Number SE0020-500

Device Problems Fluid/Blood Leak (1250); Filtration Problem (2941)

Patient Problems Skin Discoloration (2074); Chemical Exposure (2570)

Event Date 03/31/2022

Event Type  malfunction  

Event Description

Patient came into the infusion clinic for epoch pump leak at the filter site.The patient was receiving a chemotherapy infusion using the epoch pump.A small amount of the chemotherapy agent leaked onto her abdomen at home according to the patient's report.The patient taped the filter with paper tape and retaped it to her abdomen, then came into the infusion clinic to be assessed.A small amount of the chemotherapy agent was noted on the paper tape upon her arrival by her nurse.The filter was assessed, and some leakage was noted at the filter site.Pink spots were noted on the patient's abdomen.The epoch pump was discontinued and taken to (b)(6) pharmacy.The spots on the patient's abdomen from the leak reportedly did not itch or hurt.

• Brand Name: SMARTEZ PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED; 144 research drive; hampton VA 23666
• MDR Report Key: 14192360
• MDR Text Key: 289972161
• Report Number: 14192360
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/07/2022

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 Model Number: SE0020-500
• Device Lot Number: S21K009
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/07/2022
• Event Location: Other
• Date Report to Manufacturer: 04/25/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/25/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18615 DA
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Race: White