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	Hematuria (2558)
Date of Event	09/02/2026
Type of Reportable Event	Other

• 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 ; +1(847)550-2300
• MDR Report Key: 50920795
• Report Number: 3004548776-2026-00400
• Device Sequence Number: 5394209
• Product Code: GKT
• UDI-Device Identifier: 00810020441116
• UDI-Public: 00810020441116
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Device Model Number: 6R2600P
• Device Catalogue Number: 6R2600P
• Device Lot Number: FA26C17040
• 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: 09/02/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/17/2026
• 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
• Patient Sex: Unknown