MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. INTERLINK; SET, BLOOD TRANSFUSION

Model Number	2C6700
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Nurse was about to administer packed rbc's [red blood cells].After spiking the bag, nurse went to hang and prime drip chamber.As he was priming drip chamber, iv tubing separated from the drip chamber, causing blood to pour freely from chamber and bag until it could be re-spiked with new sterile blood tubing.Blood contamination occurred of iv pumps, iv pole, iv power shelf, patient bed, and floor.Contamination disinfected and sterilized.Iv tubing number (01) 00085412068152 lot (10) r24j19024.

• Brand Name: INTERLINK
• Common Device Name: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; 25212 w. illinois; route 120; round lake IL 60073
• MDR Report Key: 23554090
• Report Number: 23554090
• Device Sequence Number: 18682053
• Product Code: BRZ
• UDI-Device Identifier: 00085412068152
• UDI-Public: (01)00085412068152
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/27/2025
• Report Date (Section F): 10/27/2025

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 Model Number: 2C6700
• Device Catalogue Number: 2C6700
• Device Lot Number: R24J19024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/14/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/14/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 10/27/2025