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	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/04/2026
Type of Reportable Event	Death
Event or Problem Description
An email from biomat phenix city on september 4, 2026 stated they are investigating a donor fatality.The donor was a qualified 55-year-old male that presented for a routine donation on (b)(6) 2026 and completed an uncomplicated donation which began at 07:29 am and ended at 08:08 am.The donor donated 627 ml of plasma with a total collection volume of 704 ml.There were no collection exceptions or unusual events noted during his donation.The donor had no adverse events during the donation.The donor center was informed by a neighbor of the donor that he died on (b)(6) 2026.Information received from the local coroner indicated that the donor was home working in the garden after he donated when he developed chest pain and requested pepto-bismol from a neighbor.He collapsed at the neighbor's home, ems was contacted and they attempted to resuscitate him.However, ems was never able to obtain a pulse and the donor was pronounced deceased at 12:03 pm.The donor had reported a diagnosis of hypertension for which he had been prescribed losartan.No autopsy was performed.Toxicology samples were collected and expected to take several months for results.The coroner did indicate that a family member reported a past history of drug use but no evidence of drug use was noted at the scene.The donor was a 55-year-old male, height was 5'8 and weighed approximately 142 lbs, with a reported history of hypertension for which he had been prescribed losartan.The donor's blood pressure on the day of donation was 151/90, which was within fda allowable limits for donation of 180/100.The donor completed a routine plasmapheresis procedure on the day of the event.The donation was reportedly uncomplicated, with no adverse events, collection exceptions, unusual events, or device alarms noted during the procedure.The donor donated approximately 627 ml of plasma with a total collection volume of 704 ml, and available device logfile review demonstrated that the procedure operated within expected parameters, collection and saline reinfusion targets were achieved, and no procedural abnormalities were identified.Following donation, the donor reportedly went home and engaged in gardening activities.Several hours later, he developed chest pain, collapsed, and was pronounced deceased despite attempted resuscitation by emergency medical services.No autopsy was performed, toxicology results remain pending, and the exact cause of death is unknown.No kit sample is available for evaluation.The batch record fa26d08013 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.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 ; +1(847)550-2300
• MDR Report Key: 50920792
• Report Number: 3004548776-2026-00401
• Device Sequence Number: 5394207
• Product Code: GKT
• UDI-Device Identifier: 00810020441116
• UDI-Public: 00810020441116
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 6R2600P
• Device Catalogue Number: 6R2600P
• Device Lot Number: FA26D08013
• 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: 09/04/2026
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 55 YR
• Patient Sex: Male