MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION INTERLINK; SET, BLOOD TRANSFUSION

Model Number	2C6750H
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3/d10: the event occurred december 11-12, 2024.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that two (2) interlink system y-type blood/solution sets leaked blood shortly after the blood transfusion started on a patient.There appeared to be a hole in the tubing.The transfusion was stopped and new blood tubing was used to continue treatment.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information: b5, d4 expiration date (update to n/a), h4, h6, h11.B5: upon additional information, the location of the hole was past the two upper chambers and in the line leading to the patient.H11: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The devices were discarded; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: INTERLINK
• Common Device Name: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; piisa industrial park antigua; carretera sanchez km 18 1/2; haina, san cristobal 91000 ; DR 91000
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 21107681
• Report Number: 1416980-2024-07899
• Device Sequence Number: 8153310
• Product Code: BRZ
• UDI-Device Identifier: 00085412073583
• UDI-Public: (01)00085412073583(10)DR24G19017
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K993120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2025

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
• Operator of Device: Other
• Device Model Number: 2C6750H
• Device Catalogue Number: 2C6750H
• Device Lot Number: DR24G19017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2024
• Supplement Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BLOOD PRODUCT.
• Patient Age: 28 YR
• Patient Sex: Male