MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EXECTAMIX 2400 VALVE SET; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Model Number H938724

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 03/26/2022

Event Type  malfunction  

Event Description

During tpn compounding process, our pharmacy team identified a leaking port on the baxter valve sets.Allowing mvi (yellow color) into compounded bags (not intended), uncertainly if there was leakage of add'l ports, noting all other ingredients are clear in color.

• Brand Name: EXECTAMIX 2400 VALVE SET
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 13995904
• MDR Text Key: 288619880
• Report Number: MW5108738
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/31/2022

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 Operator: Health Professional
• Device Model Number: H938724
• Device Catalogue Number: H938724
• Device Lot Number: 60331323
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other