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	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Loss of consciousness (2418)
Date of Event	02/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The donor is a 55-year-old female donor with a long history of successfully donating plasma at the center ((b)(6) lifetime plasma collections in the current blood establishment computer system with no previously documented donor adverse events) who presented for a routine donation on (b)(6) 2026.The only medical condition the donor had reported was hypertension for which she was prescribed losartan.The donor met all donor eligibility requirements and the donation began at 9:17am following a successful venipuncture in the left arm.During draw cycle #3 the donor began feeling unwell and lost consciousness.Ems was contacted and the donor was transported to the local hospital for evaluation.The procedure targeted a plasma collection volume of 885 ml; however, the final plasma yield was 292 ml.A total of 899 ml of whole blood was processed during the procedure.The donation was terminated during return 3 without completion of a full fluid return.No procedural saline was administered beyond priming volume.A total of 39 ml of sodium citrate anticoagulant was reportedly used during the procedure.The donation was terminated early due to the donor's symptoms which resulted in a rbc loss of less than 200 ml.It was noted that no samples could be collected from the plasma bottle as the plasma had solidified.Center medical staff followed up with the donor and she reported that she had a heart catheterization performed which did not show any blockages.No hospital medical records, diagnostic imaging reports, laboratory data, or discharge summaries have been provided to independently verify the diagnosis, indication, or findings of the hospitalization or cardiac catheterization.Routine laboratory testing beyond required pre-donation eligibility screening and viral marker testing is not performed; therefore, no additional laboratory data were available for review.The donation was performed using the aurora xi plasmapheresis system with a plasmacell xi disposable set (lot fa25k11186).Review of the disposable set batch record did not identify any manufacturing nonconformances or trends that would reasonably be associated with the reported adverse event, and the finished goods lot met all applicable acceptance criteria.A device log file review was conducted by fresenius kabi engineering.Logfile analysis demonstrated markedly reduced anticoagulant (ac) delivery during the procedure.Although the ac pump motor indicated rotation, the ac scale showed minimal change beginning in draw 1 and persisting throughout the procedure.Based on the applied whole blood to anticoagulant ratio, approximately 56 ml of anticoagulant would have been expected to be delivered after priming; however, if the ac scale reading is accurate, only approximately 12 ml of anticoagulant was delivered after priming, indicating a substantial reduction in effective anticoagulation.As a result, a significant portion of the 899 ml of whole blood processed during the procedure may have been inadequately anticoagulated.Repeated alert 10014 (ac scale and pump mismatch), five occurrences of alert 3002 (high p2 pressure), alerts related to draw and return occlusions, multiple air in line detections during return, and progressive redness detected in the plasma line by the hemoglobin detector were recorded during the procedure.The observed findings of high return pressure, draw and return occlusions, air detection events, and plasma line redness are consistent with known downstream effects of insufficient anticoagulation.While these circuit disturbances were temporally associated with reduced anticoagulant delivery, a definitive root cause for the anticoagulant flow restriction could not be established based on available data.Subsequent evaluation of the aurora xi device included completion of a test procedure data sheet (tpds).The device initially failed installation checks due to alert 2005; corrective action was taken, and the device subsequently passed all tpds testing without issue.The alert 2005 did not take place during the donation procedure itself; had it occurred, the procedure would not have commenced.Review of historical device data did not demonstrate a consistent pattern of recurrent anticoagulant flow restriction events in other procedures performed on this device.Loss of consciousness during plasma donation is a recognized adverse event and may be multifactorial, including vasovagal reactions, hemodynamic changes, or donor specific factors.A direct causal relationship between the device, disposable set, or anticoagulant delivery abnormalities and the donor's clinical outcome cannot be definitively established.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 ; 8475502300
• MDR Report Key: 24745142
• Report Number: 3004548776-2026-00137
• Device Sequence Number: 8834510
• Product Code: GKT
• UDI-Device Identifier: 00810020441116
• UDI-Public: 00810020441116
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 03/31/2026

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?: No
• Device Model Number: 6R2600P
• Device Catalogue Number: 6R2600P
• Device Lot Number: FA25K11186
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown