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

Model Number	2C6723
Medical Device Problem Code	Filtration Problem (2941)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4: unique identifier (udi) #: the lot number (10) is unknown; therefore, the udi number only will contain the device identifier (01).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported a patient developed compartment syndrome due to clots observed in the filter of a y-type blood solution set.On the day of the event, the patient received a blood transfusion and ¿blood clots¿ were observed ¿during transfusion in the filter of the blood tubing¿.After an unspecified amount of time, the patient developed compartment syndrome ¿in an extremity¿.Additionally, the facility inquired about "what is the maximum amount of blood that can go through the filter, before it should be exchanged"? no further information was available at the time of this report.
Additional Manufacturer Narrative
Additional information: b5, h6 and h11.B5: upon additional information, the initial reporter further stated "they performed research and it was found that the report of clots in the blood set had no impact on the compartment syndrome".H11: the device was not returned and the lot number is unknown; 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 - CARTAGO; 600 mts oeste de entrada; las americas parque industrial; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 21403274
• Report Number: 1416980-2025-00710
• Device Sequence Number: 13107022
• Product Code: BRZ
• UDI-Device Identifier: 00085412044811
• UDI-Public: (01)00085412044811
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2C6723
• Device Catalogue Number: 2C6723
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2025
• Supplement Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 04/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: UNSPECIFIED SOLUTION
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown