MAUDE Adverse Event Report: FENWAL INTERNATIONAL INC. PLASMACELL XI DISPOSABLE SET WITH SPIKESMART; FOR COLLECTION OF PLASMA BY MEMBRANE FILTRATION. FOR USE WITH THE AURORA XI INST

Model Number	6R2600P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	01/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The donor is a 30-year-old qualified male donor who completed a non-complicated donation on (b)(6) 2026.The donor then returned on (b)(6) 2026 to complete another routine donation and just prior to starting the donation process, informed a phlebotomist that he had recently been discharged from the hospital after experiencing an acute stroke.The donor was not permitted to donate on (b)(6) 2026.Center medical staff interviewed the donor on (b)(6) 2026, and he reported that sometime after his donation on (b)(6) 2026, he experienced loss of consciousness, slurred speech, facial droop, and left sided paralysis.This may have started after he smoked a cigarette.He was apparently hospitalized for an unknown number of days, and all of his symptoms were resolved.He did not report what treatment he received and had denied taking any medications during his visit on (b)(6) 2026.Upon review of the donor's donation record, he has never reported any medical conditions or medications.He has no history of adverse events associated with donation and deferral trends.No hospital medical records, diagnostic imaging, laboratory data, or discharge summaries have been provided to independently confirm the diagnosis, severity, or etiology of the reported event.Center staff reported that the donor did not display signs or symptoms consistent with the reported neurological event during the visit on (b)(6) 2026.Despite requests, the donor has not provided medical records to substantiate the reported diagnosis.The donation performed on (b)(6) 2026 was described as non-complicated, with no reported procedural abnormalities, acute reactions, or donor-reported symptoms during or immediately following the procedure.For this donation, the reported total collection volume was 842 ml with a plasma volume of 752 ml, and 500 ml of procedural saline was administered.The batch record for the aurora kit (fa25j07053) used during the donation on (b)(6) 2026 was reviewed.No exceptions were generated that could classify as a possible root cause of this defect.The finished good lot has passed all sampling acceptance criteria for all tests performed including in-process testing and product testing.Based on the available information, a serious adverse event occurred.However, it is not clear if the serious adverse event is related to the donor's last donation on (b)(6) 2026.Therefore, fresenius kabi is reporting this event conservatively.

• Brand Name: PLASMACELL XI DISPOSABLE SET WITH SPIKESMART
• Common Device Name: FOR COLLECTION OF PLASMA BY MEMBRANE FILTRATION. FOR USE WITH THE AURORA XI INST
• Manufacturer (Section D): FENWAL INTERNATIONAL INC.; carretera sanchez km 18.5; parque industrial itabo zona f; haina, san cristobal ; DR
• Manufacturer (Section G): FENWAL INTERNATIONAL INC.; carretera sanchez km 18.5; parque industrial itabo zona f; haina, san cristobal ; DR
• Manufacturer Contact: rebecca mccandless ; 3 corporate drive; lake zurich, IL 60047 ; 8475502913
• MDR Report Key: 24431034
• Report Number: 3004548776-2026-00062
• Device Sequence Number: 13336595
• Product Code: GKT
• UDI-Device Identifier: 00810020441116
• UDI-Public: 00810020441116
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: BK160028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/24/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 6R2600P
• Device Catalogue Number: 6R2600P
• Device Lot Number: FA25J07053
• 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: 02/02/2026
• Initial Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/07/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown