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

Lot Number C21A119

Device Problems Leak/Splash (1354); Patient Device Interaction Problem (4001)

Patient Problems Erythema (1840); Peeling (1999); Chemical Exposure (2570)

Event Date 10/21/2021

Event Type  malfunction  

Event Description

Narrative from staff: patient presented today for labs/follow up/treatment.I was asked to come to see the port prior to the cma accessing.Port area red, in an oval shape with areas of sloughing skin.Patient reports it was not sore or tender to touch.Patient does believe it has gotten worse over the past several days but is not positive.The patient explained that his chemotherapy leaked on to his skin during his last infusion.

• 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: 12786338
• MDR Text Key: 280585445
• Report Number: 12786338
• 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: 11/04/2021

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 Lot Number: C21A119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/04/2021
• Event Location: Home
• Date Report to Manufacturer: 11/10/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28470 DA
• Patient Sex: Male
• Patient Weight: 107 KG