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

Model Number	2C6750H
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
No harm to patient.Platelets were primed and hung on patient.At 15 minute check, tubing near filter leaking and dripping on to ground.Tubing disconnected and removed from patient.

• Brand Name: INTERLINK
• Common Device Name: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; 5212 w. illinois route 120; round lake IL 60073
• MDR Report Key: 24114680
• Report Number: 24114680
• Device Sequence Number: 5987108
• Product Code: BRZ
• UDI-Device Identifier: 00085412073583
• UDI-Public: (01)00085412073583
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/29/2025
• Report Date (Section F): 12/29/2025

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: 2C6750H
• Device Catalogue Number: 2C6750H
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/20/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/20/2026
• 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 Age: 20 YR
• Patient Sex: Female
• Date Report Sent to FDA: 12/29/2025