MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION IV BAG; SET, I.V. FLUID TRANSFER

Model Number 2B2074X

Device Problem Material Discolored (1170)

Patient Problem Insufficient Information (4580)

Event Date 04/22/2022

Event Type  malfunction  

Event Description

The fluid inside the iv bags was found to be discolored.There are no pictures that the discoloration can be appreciated.Manufacturer response for iv fluid, (brand not provided) (per site reporter) escalated to baxter.Baxter recommended sequestering the lots and returning samples for evaluation.More than 100 bags of this fluid found across our system within these lot numbers.

• Brand Name: IV BAG
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; one baxter parkway; deerfield IL 60015
• MDR Report Key: 14309285
• MDR Text Key: 290929851
• Report Number: 14309285
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2B2074X
• Device Lot Number: Y379519, Y376167
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/27/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/06/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other