MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION BAXTER 24 STATION COMPOUNDER; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 05/28/2022

Event Type  malfunction  

Event Description

Baxter 24 station tpn compounder valve set issue at ports 1 and 2.Fda safety report id# (b)(4).

• Brand Name: BAXTER 24 STATION COMPOUNDER
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 14622867
• MDR Text Key: 293696700
• Report Number: MW5110142
• 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: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1