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

Model Number	JC7751
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a y-type blood/solution set with standard blood filter backflowed during platelet transfusion.(b)(4) unit (291 ml) of platelets was intended to infuse over one hour.The staff primed blood tubing with sodium chloride 0.9% 500ml bag and clamped tubing connected to the normal saline bag.Spiked the platelet bag and began transfusion.Near the end of the transfusion, staff noted that the platelet bag volume had not decreased as expected and discovered that the entire 500 ml saline bag had backflowed into the platelet bag despite the clamp being fully closed.The diluted platelets were transfused within a 4 hour time frame.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information: h4, h6 (update codes), h11.Correction: d4 expiration date (update to n/a), udi #.H11: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: BLOOD RECIPIENT SET
• Common Device Name: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - HAINA; parque industrial itabo; carretera sanchez km 18 1/2; haina 21426 ; DR 21426
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242705355
• MDR Report Key: 24945476
• Report Number: 1416980-2026-01404
• Device Sequence Number: 5406597
• Product Code: BRZ
• UDI-Device Identifier: 00085412046341
• UDI-Public: (01)00085412046341(10)DR25H20055
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2026

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: Health Professional
• Device Model Number: JC7751
• Device Catalogue Number: JC7751
• Device Lot Number: DR25H20055
• 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: 03/24/2026
• Supplement Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 04/21/2026
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/21/2025
• 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: 0.9% SODIUM CHLORIDE INFUSION; PLATELET INFUSION
• Patient Sex: Unknown