MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION BAXTER EM2400 VALVE SET; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Lot Number 60331323

Device Problems Leak/Splash (1354); Defective Component (2292)

Patient Problem Insufficient Information (4580)

Event Date 03/22/2022

Event Type  malfunction  

Event Description

Faulty valve sets to be used with automated compounding devices for compounding parenteral nutrition are permitting unintended mixing of ingredients to the final solution.Specifically, lipids have leaked into final product which was not to contain lipid.Fda safety report id# (b)(4).

• Brand Name: BAXTER EM2400 VALVE SET
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 13949464
• MDR Text Key: 288311964
• Report Number: MW5108593
• Device Sequence Number: 1
• Product Code: NEP
• 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: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 60331323
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1