MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EXACTAMIX 2000 ML EVA BAGS; SET, I.V. FLUID TRANSFER

Model Number H938740

Patient Problem Insufficient Information (4580)

Event Date 11/26/2023

Event Type  malfunction  

Event Description

(b)(4) tpn (total parenteral nutrition) bags burst/leak at the seam of the bag during compounding.Reference reports: mw5148549, mw5148550.

• Brand Name: EXACTAMIX 2000 ML EVA BAGS
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 18237314
• MDR Text Key: 329668192
• Report Number: MW5148548
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/26/2023

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: H938740
• Device Lot Number: 60495068
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/29/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1